COOK G47283Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10827002472836), received between Dec 13, 2018 and May 30, 2023 — classified as 30 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2023Failure to Advance; Failure to Advance

  A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED IN A PATIENT WITH PRE-EXISTING PURE ESOPHAGEAL ATRESIA. DURING PLACEMENT, THE GAP IMAGE INTRA- PROCEDURE MEASURED 3.8MM. MAGNETS WERE PLACED EASILY PER THE INSTRUCTIONS FOR USE. PER DAILY IMAGING, THE MAGNETS DID NOT MOVE SINCE PLACEMENT. GAP OF 3.8 WHEN MAGNETS IN PLACE DID NOT CHANGE OVER 5 DAYS, SO THE MAGNETS WERE REMOVED. THIS WAS NOT A POST-APPROVAL STUDY PATIENT. A LEAK WAS NOT IDENTIFIED. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020559 ↗
• MalfunctionMay 9, 2023Failure to Advance; Failure to Advance

  A PEDIATRIC PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA, UNDERWENT PLACEMENT OF THE COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. PRIOR TO PLACEMENT, THE SURGEON PERFORMED A THORACOSCOPIC MOBILIZATION OF THE ESOPHAGEAL ENDS, TO ATTEMPT A PRIMARY THORACOSCOPIC ANASTOMOSIS. DESPITE MOBILIZATION. THERE WAS STILL A GAP OF 4.0 CM ONCE THE LOWER POUCH WAS MOBILIZED, AND NO EXTRA LENGTH WAS GAINED TO IMPROVE STABILITY OF LOWER MAGNET PRIOR TO PLACEMENT. LOWER ANASTOMOTIC POUCH WAS 1 CM ABOVE DIAPHRAGM. THE FLOURISH MAGNETS NEVER MOVED CLOSER TOGETHER OVER COURSE OF 8 DAYS AND THEY WERE REMOVED THROUGH THE SAME ORIFICE AS THEY WERE PLACED [FAILURE TO ACHIEVE ANASTOMOSIS]. THERE WAS NO LEAK ON TO ESOPHOGRAM. NO ADVERSE EVENTS WERE EXPERIENCED. THIS PATIENT WAS NOT IN THE FLOURISH POST-APPROVAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897096 ↗
• InjuryApr 26, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA HAD A FLOURISH DEVICE PLACED IN 2020. ANASTOMOSIS WAS ACHIEVED WITH THE FLOURISH DEVICE. THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THIS PATIENT'S OUTCOME: "PATIENT WITH COMPLICATIONS AFTER FLOURISH MAGNAMOSIS (PLACED IN RUSH - CHICAGO) A FEW YEARS AGO [2020]. THE PATIENT DEVELOPED A CHRONIC ANASTOMOTIC LEAK [CAPTURED IN 1037905-2021-00694] AND RECURRENT TEF. WE OPERATED ON HER THIS FRIDAY, AND IT ALMOST SEEMED LIKE THE MAGNETS HAD CREATED THE ESOPHAGEAL ANASTOMOSIS THROUGH THE LUNG TISSUE. WE TREATED FOR A CHRONIC ESOPHAGEAL ANASTOMOTIC LEAK [PREVIOUSLY CAPTURED IN 1037905-2021-00694] AND A RECURRENT TEF. WE DID A NECK DISSECTION, REDO OF RIGHT THORACOTOMY, DRAINAGE OF EMPYEMA/DECORTICATION, RESECTION OF ESOPHAGEAL STRICTURE WITH PRIMARY ANASTOMOSIS, REPAIR OF RECURRENT TEF, POSTERIOR TRACHEOPEXY." THE FOLLOWING WAS RECEIVED ON 04/28/2023: PER THE TREATING PHYSICIAN: THE FLOURISH CREATED THE ESOPHAGEAL MAGNAMOSIS THROUGH THE UPPER LOBE OF THE LUNG. THE SURGERY PERFORMED (B)(6) 2023 REPAIRED THE RECURRENT TEF. THE SURGEON FEELS THE TEF WAS THERE ALL ALONG BEFORE FLOURISH WAS USED. THE SURGERY WAS TO REPAIR EVERYTHING [PRE-EXISTIN

  Patient problems: Fistula; Insufficient Information

  MAUDE report 16816007 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE PATIENT WAS 233 DAYS OF AGE, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED. THE MAGNETS WERE PLACED IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASUREMENT WAS 4 CM. ANASTOMOSIS WAS NOT ACHIEVED AFTER 13 DAYS. SURGICAL INTERVENTION (OPEN REPAIR) WAS PROVIDED TO CLOSE THE PRE-EXISTING ESOPHAGEAL GAP AT 29 DAYS FROM REMOVAL OF THE FLOURISH DEVICE. THIS EVENT OF UNABLE TO ACHIEVE ANASTOMOSIS AND SURGICAL REPAIR OF THE PRE-EXISTING ATRETIC GAP IS CAPTURED IN EMDR 1037905-2019-00087. ON 07 FEBRUARY 2023 THROUGH INFORMATION RECEIVED VIA THE FLOURISH POST APPROVAL STUDY, IT WAS DETERMINED THAT ON THE SAME DAY OF THE PATIENT'S OPEN REPAIR SURGERY (29 DAYS AFTER FLOURISH REMOVAL), THE PATIENT WAS DIAGNOSED WITH TRACHEOMALACIA. NO TREATMENT WAS PROVIDED. THE SITE CONSIDERED THIS EVENT POSSIBLY RELATED TO BOTH THE FLOURISH DEVICE AND THE PROCEDURE, STATING ¿SOME TRACHEOMALACIA IDENTIFIED AFTER PLACEMENT OF FLOURISH DEVICE [SUBJECT OF THIS REPORT]."

  Patient problems: Wheezing

  MAUDE report 16479755 ↗
• InjuryMar 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  A PEDIATRIC PATIENT UNDERWENT PLACEMENT OF A FLOURISH DEVICE TO TREAT PRE-EXISTING ESOPHAGEAL ATRESIA. ANASTOMOSIS WAS ACHIEVED. DURING DEVICE REMOVAL, IT WAS DIFFICULT TO PASS THE WIRE GUIDE AND DIFFICULTY WAS ENCOUNTERED PUSHING THE MAGNETS OUT TOGETHER. ATTEMPTS WERE MADE TO REMOVE THE MAGNETS TOGETHER THROUGH BOTH THE MOUTH AND THE GASTROSTOMY SITE. THERE WAS MUCH MANIPULATION BY THE PHYSICIANS DURING THIS TIME. THE MAGNETS WOULD SEPARATE. THEREFORE, THE UPPER MAGNET CATHETER WAS REMOVED FROM THE MOUTH. WHEN THEY TRIED TO REMOVE THE LOWER MAGNET CATHETER FROM THE GASTROSTOMY SITE, THE MAGNET CAME LOOSE FROM THE CATHETER. THEY USED A URETERAL DILATOR TO PUSH THE MAGNET FROM THROUGH THE GASTROSTOMY SITE AND PUSH IT UP TO COME OUT OF MOUTH. THIS PATIENT IS NOT ENROLLED IN THE POST APPROVAL STUDY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16477822 ↗
• InjuryFeb 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED IN A PEDIATRIC PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA. THE SUBJECT HAD TYPE A ESOPHAGEAL ATRESIA. THE INITIAL UNTREATED GAP MEASUREMENT WAS 3 CM. AT 71 DAYS OF AGE, THE PATIENT UNDERWENT THORACOSCOPIC MOBILIZATION OF ESOPHAGEAL POUCHES. WHEN UNABLE TO BRING THE ENDS TOGETHER, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE RESULTING GAP MEASUREMENT WAS 2.5 CM. THIRTEEN DAYS AFTER PLACEMENT (84 DAYS OF AGE), ANASTOMOSIS WAS ACHIEVED, AS EVIDENCED BY CONNECTED FLOW OF CONTRAST AGENT ON ESOPHAGRAM. THE FLOURISH MAGNETS WERE REMOVED THE FOLLOWING DAY [ANASTOMOSIS ACHIEVED]. AT 4 DAYS FROM FLOURISH DEVICE REMOVAL, THE PATIENT WAS DIAGNOSED WITH ESOPHAGEAL STRICTURE, FOR WHICH NO TREATMENT WAS PROVIDED. AT 43 DAYS FOLLOWING DEVICE PLACEMENT (29 DAYS POST-REMOVAL), THE PATIENT WAS DIAGNOSED WITH NEWLY-OBSERVED PROXIMAL TEF. THIS WAS INITIALLY TREATED WITH ENDOSCOPIC INJECTION OF DEFLUX INTO PROXIMAL TEF AND SUSPENSION/SUPRAGLOTTOPLASTY, AND ANTIBIOTICS FOR PNEUMONIA (THERE WERE NO EPISODES OF PNEUMONIA). ¿MISSED PROXIMAL TEF DESPITE TWO PRE-OP BRONCHOSCOPIES¿ WAS

  Patient problems: Stenosis of the esophagus

  MAUDE report 16276943 ↗
• InjuryJan 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS ORIGINALLY REPORTED: "A PEDIATRIC PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. THE SUBJECT HAD TYPE A ESOPHAGEAL ATRESIA. THE INITIAL UNTREATED GAP MEASUREMENT WAS 5.5 CM. AT 120 DAYS FROM BIRTH, THE PATIENT UNDERWENT THOROSCOPIC MOBILIZATION OF UPPER POUCH, SCHARLI OPERATION TO MOBILIZE DISTAL ESOPHAGEAL POUCH AND PROXIMAL STOMACH INTO THORAX, RIGHT THORACOTOMY, AND PYLOROMYOTOMY. DURING THE SAME PROCEDURE, THE FLOURISH¿ PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE LENGTH OF THE RESULTING ESOPHAGEAL GAP WAS 3 CM. THE LOWER FLOURISH DEVICE WAS REPOSITIONED UNDER FLUOROSCOPY AT 1 DAY POST-PLACEMENT, AND AT 4 DAYS POST-PLACEMENT. ELEVEN DAYS AFTER PLACEMENT (131 DAYS OF AGE), ANASTOMOSIS WAS ACHIEVED, AS EVIDENCED BY CONNECTED FLOW OF CONTRAST AGENT ON ESOPHAGRAM, AND THE FLOURISH MAGNETS WERE REMOVED. THE FIRST DILATION OF STRICTURE AT THE ANASTOMOTIC SITE OCCURRED 36 DAYS FOLLOWING DEVICE REMOVAL. THE PATIENT UNDERWENT SUBSEQUENT DILATION 49, 61, 74, 91, 98, 112 (+ STEROID INJECTION), 133 (+ STEROID INJECTION), 158, 180, 207 (+ STENT PLACEME

  Patient problems: Stenosis of the esophagus

  MAUDE report 16163983 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PRE-EXISTING PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. SEVENTEEN (17) DAYS POST-PLACEMENT, SUCCESSFUL ANASTOMOSIS WAS ACHIEVED. THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. AT 17 DAYS FOLLOWING FLOURISH DEVICE PLACEMENT, THE PATIENT WAS DIAGNOSED WITH A LEFT PNEUMOTHORAX AND RESPIRATORY INSUFFICIENCY. TREATMENT INCLUDED PLACEMENT OF A ¿12 FRENCH CHEST TUBE PLACED IN L PLEURAL CAVITY¿ AND MONITORING. THE PNEUMOTHORAX RESOLVED 10 DAYS AFTER ONSET AND THE RESPIRATORY INSUFFICIENCY RESOLVED 13 DAYS AFTER ONSET. THE STUDY SITE ASSESSED THE PNEUMOTHORAX AS ¿POSSIBLY¿ RELATED TO THE FLOURISH DEVICE AND NOTED THE FOLLOWING, ¿UNKNOWN IF THERE WAS SMALL LEAK CAUSED BY DEVICE LEADING TO PTX¿ AND ¿POSSIBLY¿ RELATED TO THE STUDY PROCEDURE AND NOTED THE FOLLOWING, ¿USE OF DEVICE MAY HAVE CAUSED SMALL LEAK.¿ THE RESPIRATORY INSUFFICIENCY WAS CONSIDERED ¿POSSIBLY¿ RELATED TO BOTH DEVICE AND PROCEDURE AS WELL; THE SITE NOTED THAT THE RESPIRATORY INSUFFICIENCY WAS RELATED TO THE PNEUMOTHORAX. DEFINITION PROVIDED OF "POSSIBLY RELATED": THE RELATIONSHIP IS WEAK BUT CANNOT BE COMPLETELY RULED OUT.

  Patient problems: Pneumothorax; Respiratory Insufficiency

  MAUDE report 15774492 ↗
• InjuryOct 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL DEVICE PLACEMENT. AT 5 DAYS OF AGE, BEFORE THE FLOURISH WAS PLACED, THE PATIENT UNDERWENT RIGID BRONCHOSCOPY AND EXPLORATORY THORACOTOMY. AT 26 DAYS OF AGE, BEFORE THE FLOURISH WAS PLACED, A GAP STUDY WAS PERFORMED, HOWEVER, MEASUREMENTS WERE NOT PROVIDED. AT 50 DAYS OF AGE, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. A PRE-PROCEDURE GAP MEASUREMENT WAS NOT REPORTED. AT COMPLETION OF THE PROCEDURE THE FLOURISH MAGNETS WERE IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASUREMENT WAS NOT REPORTED, BUT STATED "POUCHES ARE IN CLOSE PROXIMITY ON FLUOROSCOPY¿. NO ADDITIONAL PROCEDURES WERE REPORTED. AT 17 DAYS POST-PLACEMENT, ANASTOMOSIS WAS ACHIEVED. METHOD OF CONFIRMATION WAS NOTED AS FOLLOWS: PER EMR: "UTILIZING BOTH ENDOSCOPES, WE WERE THEN ABLE TO PASS A BIOPSY WIRE FROM THE UPPER POUCH DOWN INTO THE LOWER POUCH AND INTO THE STOMACH." THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. FIVE (5) DAYS FOLLOWING FLOURISH DEVICE REMOVAL, THE PATIENT WAS TREATED FOR STRICTURE AT THE ANASTOMOTIC SITE AND

  Patient problems: Stenosis of the esophagus

  MAUDE report 15649891 ↗
• InjuryAug 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  FLOURISH POST-APPROVAL STUDY 17-09; PT # (B)(6). AT 3 DAYS FROM BIRTH, THE PATIENT UNDERWENT THORACOTOMY FOR REPAIR OF THE TEF. AT 405 DAYS FROM BIRTH THE PATIENT UNDERWENT RIGID BRONCHOSCOPY, FLEXIBLE ESOPHAGOSCOPY AND ESOPHAGEAL DILATION. AT 453 DAYS OF AGE, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. A RESULTING GAP MEASUREMENT (FOLLOWING PLACEMENT) WAS NOT PROVIDED. NO ADDITIONAL PROCEDURES WERE REPORTED. SIX DAYS AFTER PLACEMENT (459 DAYS OF AGE), ANASTOMOSIS WAS ACHIEVED AND THE FLOURISH MAGNETS WERE REMOVED. METHOD OF CONFIRMATION OF ANASTOMOSIS WAS NOT PROVIDED. THE FIRST DILATION OF STRICTURE AT THE ANASTOMOTIC SITE OCCURRED 12 DAYS FOLLOWING DEVICE REMOVAL. THE PATIENT UNDERWENT SUBSEQUENT DILATION 24, 35, 64, 113, AND 246 DAYS FOLLOWING DEVICE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis of the esophagus

  MAUDE report 15165616 ↗
• InjuryFeb 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO COOK REGARDING A PATIENT WHO HAD BEEN TREATED WITH THE COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. AT 7 DAYS OF AGE THE PATIENT UNDERWENT ESOPHAGOGASTRODUODENOSCOPY WITH DILATION OF GASTRIC/DUODENAL STRICTURES. AT 56 DAYS OF AGE THE PATIENT UNDERWENT FLEXIBLE BRONCHOSCOPY. THE PATIENT UNDERWENT THORACOTOMY AT 60 DAYS OF AGE WITH THE FULL REPAIR OF THE TEF OCCURRING AT 63 DAYS OF AGE (DATE OF FLOURISH DEVICE PLACEMENT). THE INITIAL (UNTREATED) GAP MEASURED 2 CM. AT 60 DAYS OF AGE, THE FLOURISH¿ PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. AT COMPLETION OF THE PROCEDURE THE FLOURISH MAGNETS WERE IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASUREMENT WAS NOT REPORTED. ADDITIONAL PROCEDURES INCLUDED, ¿DISTAL FISTULA TAKEDOWN¿. AT 8 DAYS POST-PLACEMENT, ANASTOMOSIS WAS CONSIDERED ACHIEVED WITH AN ESOPHAGRAM SHOWING CONNECTED FLOW OF CONTRAST AGENT (SUCCESSFUL ANASTOMOSIS). THE FLOURISH DEVICE WAS REMOVED ON THE SAME DAY. THE PATIENT UNDERWENT THE FIRST ESOPHAGEAL DILATION FOR STRICTURE AT THE ANASTOMOTIC SITE AT 24 DAYS FOLLOWING FLOURISH DEVICE REMOVAL. THE SITE REPORTED AN ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis of the esophagus

  MAUDE report 13506992 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PEDIATRIC PATIENT WITH CONGENTIAL PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. SUCCESSFUL ANASTOMOSIS WAS ACHIEVED. DILATION OF THE ANASTOMOSIS WAS PERFORMED (SEE MDR 1037905-2021-00613). AT 53 DAYS POST-PLACEMENT, AN ESOPHAGEAL LEAK WAS SUSPECTED AT THE ANASTOMOTIC SITE. THE SITE NOTED, ¿EVEN THOUGH THERE WAS NO DEMONSTRATED LEAK ON THE ESOPHAGOGRAM SHE CONTINUED TO HAVE A CLINICAL ESOPHAGEAL LEAK WITH SALIVA DRAINING FROM HER CHEST TUBE. THIS WAS A CLINICAL LEAK THAT NEEDED TO BE TREATED AND SINCE SHE DIDN¿T HAVE ANY RECENT ESOPHAGEAL SURGERY EXCEPT FOR THE MAGNET PLACEMENT AND THIS BEGAN AFTER MAGNET PLACEMENT THIS WAS CONSIDERED TO BE FROM THE DEVICE.¿ THE SITE ALSO NOTED, ¿HAD A LEAK FROM UPPER POUCH AND MULTIPLE SURGERIES BUT CONCERN WAS THAT MAGNETS DIDN'T COME TOGETHER END TO END AND POSSIBLY SIDE TO SIDE POSSIBLY RELATED LEAK.¿ IT WAS ALSO NOTED, BY THE SITE, THAT THE EVENT DID NOT LEAD TO A SERIOUS INJURY OR ILLNESS. TREATMENT INCLUDED, AS NOTED BY THE SITE, ¿INTERVENTIONAL RADIOLOGY PLACEMENT OF DRAINAGE INTO LOCULATED POSTEROLATERAL APICAL HYDROPNEUMOTHORAX. DRAIN SET TO BULB SUCTION.¿

  Patient problems: Laceration(s) of Esophagus; Perforation of Esophagus

  MAUDE report 13018904 ↗
• InjuryDec 6, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  A PEDIATRIC PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA HAD A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE PLACED. FIVE DAYS POST-PLACEMENT, ANASTOMOSIS WAS ACHIEVED. AT 21 DAYS POST FLOURISH REMOVAL, THE PATIENT UNDERWENT ESOPHAGEAL DILATION FOR STRICTURE AT THE ANASTOMOTIC SITE. THE SITE REPORTED ADDITIONAL DILATIONS OCCURRING AT 27, 37, 42, 49, 56, 68, AND 74 DAYS POST-PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. THE PATIENT REQUIRED DILATION AT THE ANASTOMOTIC SITE DUE TO A STRICTURE. THERE WERE NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis of the esophagus

  MAUDE report 12934344 ↗
• MalfunctionNov 17, 2021Failure to Advance; Failure to Advance

  A PEDIATRIC PATIENT WITH PRE-EXISTING CONGENITAL ESOPHAGEAL ATRESIA HAD A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE PLACED. THE DATE OF DEVICE PLACEMENT WAS (B)(6) 2021. THE ORIGINAL ATRETIC GAP IMAGING PROVIDED BY THE SURGEON WAS APPROXIMATE 2.2CM IN LENGTH. TO MEASURE, A FLEXIBLE CATHETER WAS USED ON THE UPPER POUCH AND A METAL PROBE WAS USED IN THE LOWER POUCH. ON THE DAY OF THE PROCEDURE THE GAP WAS APPROXIMATE 4CM IN LENGTH. THE PATIENT HAD A SHORT UPPER POUCH AND A LONG LOWER POUCH. AFTER SEVEN INDWELLING DAYS, THE MAGNETS FAILED TO ALIGN. THEY DID NOT SHOW ANY SIGNS OF MAGNETIC ATTRACTION. THE SURGEON DECIDED TO STOP THE TREATMENT WITH THE FLOURISH DEVICE. ON (B)(6) 2021 THE FLOURISH DEVICE WAS REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830116 ↗
• InjuryNov 10, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WITH PRE-EXISTING CONGENITAL ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH ESOPHAGEAL ATRESIA DEVICE. WHEN THE PATIENT WAS (B)(6), THE FLOURISH¿ PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. AT THE COMPLETION OF THE PROCEDURE, THE MAGNETS WERE IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASURED 2.2 CM. NO ADDITIONAL PROCEDURES WERE PERFORMED. ANASTOMOSIS WAS ACHIEVED AND THE FLOURISH DEVICE WAS REMOVED 30 DAYS POST-PLACEMENT. THE FIRST DILATION FOR STENOSIS AT THE ANASTOMOTIC SITE OCCURRED 101 DAYS AFTER REMOVAL OF THE FLOURISH DEVICE [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT. THE PATIENT EXPERIENCED A STRICTURE AT THE ANASTOMOSIS SITE WHICH REQUIRED DILATION. THERE WERE NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis of the esophagus

  MAUDE report 12786918 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PRE-EXISTING PEDIATRIC ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF THE COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. THE FOLLOWING WAS REPORTED: ELEVEN DAYS AFTER REMOVAL OF FLOURISH DEVICE, THE PATIENT WAS DIAGNOSED WITH A PULMONARY INFECTION (PNEUMONIA). MEDICAL TREATMENT WAS PROVIDED, ¿PROPHYLACTIC UNASYN CONTINUE FLUCONAZOLE PROPHYLAXIS 6 MG/KG TWICE WEEKLY MAINTAIN CHEST TUBE TO SUCTION AND MONITOR OUTPUT.¿ TO THE QUESTION: WAS THE EVENT CONSIDERED RELATED TO THE FLOURISH DEVICE? THE SITE MARKED ¿PROBABLY¿ AND NOTED THE FOLLOWING, ¿WORSENED CONDITION¿. SITE WAS QUERIED TO REVIEW AND CONFIRM ENTRY, AND ASSESSMENT WAS CONFIRMED. TO THE QUESTION: DID A PRE-EXISTING CONDITION CAUSE OR CONTRIBUTE TO THE EVENT? THE SITE MARKED ¿YES¿ AND NOTED THE FOLLOWING: ¿WORSENED CONDITION¿ THIS IS THE SAME PATIENT REFERENCED IN 1037905-2020-00269. A SECTION OF THE DEVICE FID NOT REMAIN IN THE PATIENT'S BODY. THE PATIENT EXPERIENCED PNEUMONIA AND REQUIRED TREATMENT AS LISTED ABOVE.

  Patient problems: Hyperventilation; Pneumonia

  MAUDE report 12683490 ↗
• InjurySep 27, 2021Failure to Advance; Failure to Advance

  THEN FOLLOWING WAS ORIGINALLY REPORTED: "A PEDIATRIC PATIENT WITH PRE-EXISTING ESOPHAGEAL ATRESIA UNDERWENT PLACEMENT OF A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE. THE DEVICE WAS PLACED IN THE ESOPHAGEAL POUCHES. THIS PATIENT WAS ALREADY TREATED WITH THE FLOURISH DEVICE ON (B)(6) 2021. THE PROCEDURE WAS UNSUCCESSFUL AND A COMPLAINT WAS SUBMITTED AT THAT TIME (SEE COOK REFERENCE 1037905-2021-00326). THE PHYSICIAN REPEATED AN ESOPHAGRAM ON THE SAME PATIENT MID AUGUST AND SAW THAT THE GAP SEEMED TO BE A BIT CLOSER TOGETHER SO HE TRIED USING THE FLOURISH DEVICE ONCE AGAIN. THE PHYSICIAN PLACED THE FLOURISH DEVICE ON (B)(6) 2021. HE THEN CHECKED PLACEMENT ON (B)(6) 2021 AND SAW THAT THE LOWER MAGNET WAS NOT STAYING AT THE MOST DISTAL END OF THE ESOPHAGEAL POUCH. THIS HAD OCCURRED WITH THE PROCEDURE DONE ON (B)(6) 2021. HE REALIZED THAT THE LOWER POUCH WAS NOT GOING TO HOLD THE MAGNET IN PLACE SO HE DECIDED TO REMOVE THE FLOURISH DEVICE ALTOGETHER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537694 ↗
• InjuryJul 19, 2021Failure to Advance; Failure to Advance

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED: FLOURISH DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2021. A REPLOGLE TUBE WAS ALSO PLACED. DURING INDWELLING TIME THE MAGNETS DID NOT PROGRESS OR MOVE. ON (B)(6) 2021, THE SURGEON DECIDED TO REMOVE THE MAGNETS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WILL REQUIRE THE SURGICAL APPROACH TO TREAT THE ESOPHAGEAL ATRESIA. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Failure to Anastomose

  MAUDE report 12193557 ↗
• InjuryJul 19, 2021Failure to Advance; Failure to Advance

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED: FLOURISH DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2021. DURING INDWELLING TIME THE MAGNETS DID NOT PROGRESS OR MOVED. ON (B)(6) 2021 THE SURGEON DECIDED TO REMOVE THE MAGNETS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WILL REQUIRE THE SURGICAL APPROACH TO TREAT THE ESOPHAGEAL ATRESIA. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Failure to Anastomose

  MAUDE report 12193193 ↗
• InjuryJun 3, 2021Failure to Advance; Failure to Advance

  THE FOLLOWING WAS ORIGINALLY REPORTED: THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED FLOURISH DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2020. DURING INDWELLING TIME THE MAGNETS DID NOT PROGRESS/MOVE [FAILURE TO ACHIEVE ANASTOMOSIS]. ON (B)(6) 2020 THE SURGEON DECIDED TO REMOVE THE MAGNETS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." THE FOLLOWING WAS RECEIVED ON 02/07/2022: THIS PATIENT IS NOW IN THE POST APPROVAL STUDY. THE PATIENT UNDERWENT DISTAL TEF LIGATION OCCURRED AT TWO DAYS OF AGE; PROXIMAL TEF LIGATION AND TRACHEOSTOMY OCCURRED AT 44 DAYS OF AGE. THE INITIAL (UNTREATED) GAP MEASUREMENT WAS NOT PROVIDED. WHEN THE PATIENT WAS 121 DAYS OF AGE, THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED WITH THE PATIENT UNDER GENERAL ANESTHESIA. AT THE COMPLETION OF THE PROCEDURE, THE MAGNETS WERE IN THE DISTAL MOST PORTION OF THE ESOPHAGEAL ENDS. THE RESULTING GAP MEASUR

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931372 ↗
• InjuryMay 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED: A 5 MONTH OLD MALE PATIENT UNDERWENT A PROCEDURE OF PLACEMENT OF THE FLOURISH MAGNET CATHETER DEVICE FOR REPAIR OF ESOPHAGEAL ATRESIA IN WHICH THE FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS USED. ONE MAGNET WAS PLACED IN THE PROXIMAL ESOPHAGEAL POUCH AND A SECOND ONE WAS PLACED IN THE DISTAL ESOPHAGEAL POUCH. ON (B)(6) 2021, THE FLOURISH DEVICE WAS PLACED IN THE PATIENT AND X-RAY CONFIRMED GOOD PLACEMENT. THE SURGEON AND INTERVENTIONAL RADIOLOGY PHYSICIAN DECIDED TO LEAVE A WIRE GUIDE IN THE INNER CATHETER OF THE LOWER FLOURISH CATHETER TO USE FOR SUPPORT, THERE WAS SLIGHT CURLING OF THE INNER CATHETER IN THE STOMACH. THE PATIENT WAS TRANSFERRED TO THE NEONATAL INTENSIVE CARE UNIT (NICU), AT THE BEDSIDE AN X-RAY WAS TAKEN AND THE POSITION OF THE MAGNETS LOOKED GOOD. ON DAY TWO, THE SURGEON CALLED THE COOK REPRESENTATIVE AND INDICATED THE PROXIMAL MAGNET MOVED UP SLIGHTLY AND SHE MANIPULATED TO GET IT BACK INTO POSITION. ON DAY THREE AFTER PLACEMENT, THE SURGEON LET THE REPRESENTATIVE KNOW THAT THE DISTAL MAGNET HAD MOVED DISTALLY A

  Patient problems: Fistula

  MAUDE report 11813304 ↗
• MalfunctionMar 10, 2021Failure to Advance; Failure to Advance

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED: THE PHYSICIAN TOOK THE PATIENT TO THE OPERATING ROOM AND TRIED TO PERFORM A SURGICAL ESOPHAGEAL PRIMARY ANASTOMOSIS. THE PRIMARY REPAIR AND PLACEMENT OF MAGNETS WERE NOT SUCCESSFUL. THE DISTAL ESOPHAGUS WAS VERY THIN. THERE WAS DIFFICULTY FINDING IT [DISTAL ESOPHAGUS] INITIALLY AND A GASTROSCOPE LIGHT AND INSUFFLATION OF THE STOMACH WAS NEEDED TO IDENTIFY IT. THE DISTAL ESOPHAGUS WAS TOO SHORT AND THE MAGNET KEPT SLIDING OUT. THE UPPER AND LOWER MAGNETS DID NOT ¿SEE¿ EACH OTHER [UNABLE TO ACHIEVE ANASTOMOSIS]. PER THE USER, "THE DISTANCE SEEMED TO BE LONGER (MAINLY DUE TO THE DISTAL ESOPHAGUS) THAN WHAT WAS APPRECIATED WITH THE GAPOGRAM IN JANUARY, BUT STILL SHOULD HAVE BEEN WITHIN THE DISTANCE FLOURISH IS SUPPOSED TO BE EFFECTIVE FOR." THE PROXIMAL ESOPHAGUS WAS MOBILIZED QUITE WELL BUT EVEN THEN, COULD NOT APPROXIMATE THE UPPER AND LOWER POUCHES LESS THAN 2 CM WITHOUT SOME TENSION. PER THE PHYSICIAN, THE DISTAL ESOPHAGUS WAS TOO DELICATE AND THIN-WALLED TO TRY AGGRESSIVELY. ONCE THE PROCEDURE WAS ABORTED, THE MAGNETS WERE TESTED IN EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456341 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED FROM A COOK REPRESENTATIVE. THE FLOURISH DEVICE WAS INTRODUCED ON (B)(6) 2020. MAGNETS WERE REPOSITIONED POST-OPERATION IN RADIOLOGY AS THE DISTAL MAGNET SEEMED TO HAVE FALLEN OUT OF PLACE, LIKELY DURING PATIENT TRANSPORT AND/OR PATIENT HANDLING. BOTH MAGNETS WERE WELL-ALIGNED FOLLOWING REPOSITIONING. EVEN THOUGH THE ORAL MAGNET SEEMED A BIT KINKED AT FIRST, POSSIBLY DUE TO THE MANNER IN WHICH THE OUTER CATHETER WAS FIXED ONTO THE BABY¿S CHEEK, IT LATER SHOWED TO HAVE ADVANCED AND STRAIGHTENED OUT. DURING THE WHOLE TIME THE MAGNETS WERE IN PLACE, THE UPPER MAGNET WAS LEFT UNLOCKED (EXCEPT WHEN PATIENT WAS MOVED), THE LOWER MAGNET WAS KEPT LOCKED AND THE GASTRIC CATHETER (FEEDING TUBE) REMAINED IN THE DISTAL POUCH. THE MAGNETS REMAINED WELL-ALIGNED AND SHOWED GOOD PROGRESSION; THE GAP HAVING BEEN REDUCED TO 2.2 CM BY MONDAY (DAY 3). ON MONDAY, THE DISTAL MAGNET ALSO STARTED SHOWING SOME PROGRESSION, AS IT HAD MOVED A BIT UPWARDS AND OUT OF THE OUTER GASTRIC CATHETER. ON DAY 4 ((B)(6)2020), THE PATIENT STARTED TO HAVE A FEVER. IMAGING SHOWE

  Patient problems: Perforation of Esophagus

  MAUDE report 10586114 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED FROM A COOK REPRESENTATIVE. THE FLOURISH DEVICE WAS INTRODUCED INTO THE PATIENT ON (B)(6) 2020. THE PROCEDURE AND PLACEMENT OF THE DEVICE WERE NON EVENTFUL. THE ONLY THING THAT WAS DIFFERENT WAS THE GAP LENGTH. ORIGINALLY THE GAP LENGTH WAS AROUND 2 CM WHEN ORIGINAL GAP IMAGING WAS DONE. THE SURGEON DID MENTION THAT THEY WERE DOING DILATIONS ONCE PER WEEK TO TRY TO BRING THE ESOPHAGEAL ENDS TOGETHER. THEY HAD STOPPED THE DILATIONS ONCE THEY REQUESTED THE FLOURISH DEVICE. THEY STOPPED THE DILATIONS FOR TWO WEEKS UNTIL THEY USED THE FLOURISH DEVICE. AT THE TIME OF THE PROCEDURE, THE GAP LENGTH APPEARED TO BE 4 CM. AFTER PLACEMENT AND ONCE THE PATIENT WENT TO THE NEONATAL INTENSIVE CARE UNIT (NICU), IT WAS ADVISED TO LEAVE THE INNER CATHETERS IN THE UNLOCKED POSITION. THIS WAY IT COULD BE SEEN HOW LONG THE GAP WOULD BE DURING THE NEXT COUPLE DAYS AND BE ABLE TO SEE IF THERE WAS ANY PROGRESSION ON THE DAILY CHEST X-RAYS. THIS IS RECOMMENDED WITH EVERY FLOURISH PROCEDURE. THE SURGEON DECIDED TO LEAVE THE INNER CATHETERS IN THE LOCKED POSITION

  Patient problems: Perforation of Esophagus

  MAUDE report 10438200 ↗
• InjuryJul 9, 2020Failure to Advance; Failure to Advance

  THE PHYSICIAN USED A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE ON A PEDIATRIC PATIENT WITH ESOPHAGEAL ATRESIA. THE FOLLOWING WAS REPORTED: THE FLOURISH DEVICE WAS PLACED ON (B)(6) 2019. THE UPPER MAGNET WAS INTRODUCED INTO THE UPPER ESOPHAGEAL POUCH. THE LOWER MAGNET WAS INTRODUCED THROUGH THE ESTABLISHED EXISTING STOMA AND PLACED IN THE MOST DISTAL END OF THE ESOPHAGEAL POUCH. THE DEVICE WAS LEFT IN PLACE FOR EIGHT DAYS AND THE MAGNETS DID NOT MOVE OR ATTRACT. ON (B)(6) 2019, THE FLOURISH DEVICE WAS REMOVED. IT DID NOT ESTABLISH AN ANASTOMOSIS AND NO ADVERSE EVENTS WERE REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT STAYED HOSPITALIZED BECAUSE OF THE PATIENT'S PREEXISTING CONDITIONS AND ALSO FOR THE SURGICAL APPROACH TO TREAT THE ESOPHAGEAL ATRESIA. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Failure to Anastomose

  MAUDE report 10250995 ↗