DISPOSABLE BALLOON CATHETER B5-2C (UDI 04953170047398)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170047398), received between Jul 3, 2019 and Jul 11, 2025 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING AN AIR LEAK CASE TODAY, THE TEAM COULDN'T GET THE BALLOON CATHETER TO CLEAR AIR. THERE WAS NO VACUUM IN THE SYRINGE WHILE EVACUATING AIR FROM THE CATHETER. THIS HAPPENED WITH BOTH BALLOON CATHETERS IN THE AIR LEAK KIT. THEY TRIED THREE DIFFERENT SYRINGES TO ENSURE THE SYRINGE WASN'T THE POINT OF FAILURE. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 2 OF 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477392 ↗
• MalfunctionJul 11, 2025Gas/Air Leak; Failure to Deflate; Gas/Air Leak; Failure to Deflate

  IT WAS REPORTED DURING AN AIR LEAK CASE TODAY, THE TEAM COULDN'T GET THE BALLOON CATHETER TO CLEAR AIR. THERE WAS NO VACUUM IN THE SYRINGE WHILE EVACUATING AIR FROM THE CATHETER. THIS HAPPENED WITH BOTH BALLOON CATHETERS IN THE AIR LEAK KIT. THEY TRIED THREE DIFFERENT SYRINGES TO ENSURE THE SYRINGE WASN'T THE POINT OF FAILURE. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477369 ↗
• InjuryFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN EMERGENCY BRONCHOSCOPY TO RETRIEVE A FOREIGN BODY (GARDEN PEA) FROM A PATIENT'S LUNG THE PHYSICIAN ATTEMPTED TO RETRIEVE USING A BALLOON CATHETER MODEL-B5-2C. THE FIRST BALLOON DISLODGED AND THE SECOND BALLOON WAS USED THAT GOT DETACHED, THUS THE PHYSICIAN WAS UNABLE TO RETRIEVE EITHER. THE PATIENT WENT TO CARDIOTHORACIC IN THE RIE FOR TREATMENT. THE CUSTOMER LATER CONFIRMED THE DETACHED PART WAS THE B5-2C AND THE TUBE DISTAL TO THE BALLOON. THE TUBE PROXIMAL TO THE BALLOON WAS STILL ATTACHED. THE PROCEDURE WAS EXTENDED BY A FEW MINUTES. AFTER THE BALLOON DETACHED THE BRONCHOSCOPIST USED FORCEPS TO ATTEMPT TO RETRIEVE THE DEVICE. AS THERE WAS SOME BLEEDING AND THE PATIENT WAS NOT WELL SEDATED/COMFORTABLE THE PROCEDURE WAS ENDED AND THE PATIENT WAS TRANSFERRED TO ROYAL INFIRMARY OF EDINBURGH FOR A RIGID BRONCHOSCOPY. THE CUSTOMER ADVISED THAT THE REASON FOR THE TRANSFER WAS NOT DUE TO THE BLEED BUT BECAUSE OF THE FOREIGN BODY (PEA) THAT WAS THE ORIGINAL REASON FOR THE PROCEDURE. THE CT SCAN SHOWED NO EVIDENCE OF EITHER THE BALLOON OR THE FOREIGN BODY (PEA). THE VIEW OF THE RESPIRATORY PHYSICIAN IS THAT THESE MAY HAVE BEEN COUGHED UP DURING THE PATIENT¿S SLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21444748 ↗
• MalfunctionJun 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE INTENDED PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602250 ↗
• MalfunctionMar 19, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THE BALLOON CATHETER HAD POSSIBLE BLOOD ON THE OUTSIDE OF THE PACKAGE. THE ISSUE OCCURRED DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935417 ↗
• InjuryMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN EMERGENCY BRONCHOSCOPY TO RETRIEVE A FOREIGN BODY (GARDEN PEA) FROM A PATIENT'S LUNG THE PHYSICIAN ATTEMPTED TO RETRIEVE USING A BALLOON CATHETER. THE BALLOON DISLODGED AND THEY WERE UNABLE TO RETRIEVE EITHER WITH A FORCEPS. THE CUSTOMER LATER CONFIRMED THE DETACHED PART WAS THE BALLOON AND THE TUBE DISTAL TO THE BALLOON. THE TUBE PROXIMAL TO THE BALLOON WAS STILL ATTACHED. THE PROCEDURE WAS EXTENDED BY A FEW MINUTES. AS THERE WAS SOME BLEEDING AND THE PATIENT WAS NOT WELL SEDATED OR COMFORTABLE; THEREFORE, THE PROCEDURE WAS DISCONTINUED AND THE PATIENT WAS TRANSFERRED TO CARDIOTHORACIC AT ROYAL INFIRMARY OF EDINBURGH FOR A RIGID BRONCHOSCOPY. THE CUSTOMER ADVISED THAT THE REASON FOR THE TRANSFER WAS NOT DUE TO THE BLEED BUT BECAUSE OF THE FOREIGN BODY (PEA) THAT WAS THE ORIGINAL REASON FOR THE PROCEDURE. THE CT SCAN SHOWED NO EVIDENCE OF EITHER THE BALLOON OR THE FOREIGN BODY (PEA). THE RESPIRATORY PHYSICIAN THOUGHT THE PATIENT MAY HAVE COUGHED THEM UP DURING SLEEP AND POTENTIALLY SWALLOWED. NO ADDITIONAL PROCEDURES WERE REQUIRED AFTER THE RIGID BRONCHOSCOPY AND CT SCAN. THE PATIENT HAS SHOWN NO SUBSEQUENT ADVERSE EFFECTS AND THE PATIENT HAS RETURNED TO N

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18833780 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF RADIAL ENDOBRONCHIAL ULTRASOUND FOR PERIPHERAL PULMONARY LESIONS WITHOUT AUTOMATION TECHNOLOGY IN TUBERCULOUS ENDEMIC REGION: REAL-WORLD EXPERIENCE IN A SINGLE INSTITUTION OVER 6 YEARS." THIS IS A RETROSPECTIVE CHART REVIEW OF ALL ADULT PATIENTS UNDERGOING RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS)-GUIDED TRANSBRONCHIAL BIOPSY FOR PERIPHERAL PULMONARY LESIONS (PPL) IN OUR INSTITUTION OVER 6 YEARS DURATION (OCTOBER 2016 TO DECEMBER 2022). VARIOUS FLEXIBLE CONVENTIONAL (BF-H190), THIN BRONCHOSCOPES (BF-MP190-F), RADIAL EBUS PROBES (K-201) AND AN ENDOBRONCHIAL BALLOON (B5-2C) WERE USED FOR THE PROCEDURES. DURING THE STUDY PERIOD, A TOTAL OF 558 PROCEDURES WERE PERFORMED. SEVEN CASES WERE EXCLUDED DUE TO THE PRESENCE OF VISIBLE ENDOBRONCHIAL LESIONS DURING INITIAL SCOUTING BRONCHOSCOPY. THE FINAL NUMBER OF PROCEDURES AVAILABLE FOR ANALYSIS WAS 551. PNEUMOTHORAXES: 1.1% - REQUIRING PERCUTANEOUS DRAINAGE MILD BLEEDING: 22.1% MODERATE BLEEDING: 5.3%

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 18740970 ↗
• MalfunctionFeb 1, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE DISPOSABLE BALLOON CATHETER DID NOT DEFLATE AFTER BEING INFLATED INTRACORPOREALLY. THE SUBJECT DEVICE BECAME SMALLER DURING VARIOUS OPERATIONS SO THEY PULLED THE DEVICE OUT OF THE BODY. NO PARTS OF THE SUBJECT DEVICE FELL OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE THERE WERE NO REPORTS OF PATIENT HARM OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623954 ↗
• InjuryDec 4, 2023Material Rupture; Material Rupture

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, AT THE BEGINNING OF THE THERAPEUTIC PROCEDURE FOR A PROLONGED AIR LEAK, THE USER BLEW UP THE DISPOSABLE BALLOON CATHETER PAST ITS CAPACITY TRYING TO FILL THE ENTIRE AIRWAY, AND IT POPPED CAUSING A FIVE MINUTE DELAY. THE USER WAS ABLE TO QUICKLY REMOVE THE POPPED BALLOON WITH FORCEPS, AND THE AIRWAY WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THERE WAS NO BALLOON DEBRIS LEFT IN THE AIRWAY AND NO FURTHER INTERVENTION WAS NECESSARY. THREE 9MM SPIRATION VALVES WERE PLACED IN THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW BALLOON CATHETER AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264081 ↗
• InjuryDec 4, 2023Material Rupture; Material Rupture

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, AT THE BEGINNING OF THE THERAPEUTIC PROCEDURE FOR A PROLONGED AIR LEAK, THE USER BLEW UP THE DISPOSABLE BALLOON CATHETER PAST ITS CAPACITY TRYING TO FILL THE ENTIRE AIRWAY, AND IT POPPED CAUSING A FIVE MINUTE DELAY. THE USER WAS ABLE TO QUICKLY REMOVE THE POPPED BALLOON WITH FORCEPS, AND THE AIRWAY WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THERE WAS NO BALLOON DEBRIS LEFT IN THE AIRWAY AND NO FURTHER INTERVENTION WAS NECESSARY. THREE 9MM SPIRATION VALVES WERE PLACED IN THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW BALLOON CATHETER AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264074 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Pneumothorax; Respiratory Failure

  MAUDE report 16555529 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OFF-LABEL USE OF INTRABRONCHIAL VALVES FOR PERSISTENT AIR LEAK IS SAFE AND EFFECTIVE: A RETROSPECTIVE CASE ANALYSIS". PERSISTENT AIR LEAK (PAL) IS A CHALLENGING CLINICAL PROBLEM ASSOCIATED WITH PROLONGED HOSPITAL STAY AND INCREASED MORBIDITY. HISTORICALLY, TREATMENT OPTIONS WERE LIMITED TO THORACOSTOMY TUBE DRAINAGE, PLEURODESIS, AND SURGICAL REPAIR. THE DEVELOPMENT OF ONE-WAY AIRWAY VALVES HAS REPRESENTED A PARADIGM SHIFT IN PAL MANAGEMENT. WE PRESENT OUR EXPERIENCE USING INTRABRONCHIAL VALVES (IBVS) FOR PAL MANAGEMENT LOOKING AT BOTH ON-LABEL (POST-THORACIC SURGERY) AND OFF-LABEL (ALL OTHER) INDICATIONS. DURING THE STUDY PERIOD, 15 PATIENTS UNDERWENT IBV INSERTION FOR PAL. THE ON-LABEL COHORT CONTAINED THREE PATIENTS (POST LOBECTOMY OR SEGMENTECTOMY). THE OFF-LABEL COHORT HAD 12 PATIENTS. (6 EMPYEMA, 4 SECONDARY SPONTANEOUS PNEUMOTHORAX, 1 PENETRATING TRAUMA, AND 1 POST PERCUTANEOUS LUNG NODULE BIOPSY). IN THE ON-LABEL COHORT, CHEST TUBE WAS REMOVED AFTER A MEAN DURATION OF 4.0±1.0 DAYS FOR ALL PATIENTS. IN THE OFF-LABEL COHORT, 83.3% (10/12) HAD CHEST TUBE REMOVAL 16.2±5.7 DAYS (P=0.396) AFTER IBV PLACEMENT. ONE PATIENT DEVELOPED

  Patient problems: Pneumothorax; Respiratory Failure

  MAUDE report 16555337 ↗
• MalfunctionAug 31, 2022Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A DISPOSABLE BALLOON CATHETER, AFTER INFLATION DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEFLATED AND IT COULD NOT BE REMOVED. THE BALLOON WAS CUT FROM THE BASE OF THE HANDLE OF THE TREATMENT INSTRUMENT, REPLACED WITH A SCOPE, AND REMOVED. COMPLETED THE PROCEDURE WITH THE ACTUAL PRODUCT WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328786 ↗
• InjuryMay 11, 2022Separation Problem; Separation Problem

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A BRONCHOSCOPY FOR FOREIGN MATTER (TEETH) REMOVAL, THE BALLOON TIP CAME INTO CONTACT WITH THE SHARP EDGE OF THE TEETH UPON REMOVAL, BROKE, AND SIMULTANEOUSLY FELL INTO THE PATIENT'S LUNGS (BRONCHUS, POSTERIOR SEGMENT LEFT LUNG). THE SHAPE OF THE ENDOSCOPE FIT THE LEFT LUNG LOCATION AND THE ENDOSCOPE ANGLE STATE WAS UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE TEETH WERE REMOVED WITH BASKET FORCEPS. THE PHYSICIAN WAS UNABLE TO LOCATE THE DEVICE FRAGMENT BUT IT WAS CONFIRMED IN THE LUNGS BY UNPLANNED DIAGNOSTIC X-RAY. THE DEVICE FRAGMENT WAS LEFT IN THE PATIENT. THERE WAS NO RESISTANCE WHEN PASSING THE BALLOON CATHETER THROUGH THE BACK OF THE FOREIGN BODY. THE CLEARANCE WAS NARROW BETWEEN THE FOREIGN BODY AND THE BRONCHUS LUMEN. THE PHYSICIAN ATTEMPTED TO LOCATE AND RETRIEVE THE DEVICE FRAGMENT WITH A THIN ENDOSCOPE BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAS ADMINISTERED THE PATIENT COUGH-INDUCING MEDICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14360036 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: DIAGNOSTIC YIELD OF TRANSBRONCHIAL CRYOBIOPSY GUIDED BY RADIAL ENDOBRONCHIAL ULTRASOUND AND FLUOROSCOPY IN THE RADIOLOGICALLY SUSPECTED LUNG CANCER: A SINGLE INSTITUTION PROSPECTIVE STUDY BY VYTAUTAS ANKUDAVICIUS, ET AL. ABSTRACT TRANSBRONCHIAL CRYOBIOPSY (TBCB) IS BEING STUDIED IN THE DIAGNOSIS OF PERIPHERAL LUNG LESIONS; HOWEVER, THERE ARE ONLY A FEW CLINICAL STUDIES AROUND THE WORLD. THE AIM OF OUR STUDY WAS TO EVALUATE THE DIAGNOSTIC VALUES AND SAFETY OF TRANSBRONCHIAL CRYOBIOPSY FOR RADIOLOGICALLY SUSPECTED PERIPHERAL LUNG CANCER. THE PROSPECTIVE CLINICAL STUDY WAS EXECUTED FROM SEPTEMBER 2019 TO SEPTEMBER 2021 AT A TERTIARY CLINICAL CENTRE IN LITHUANIA. A TOTAL OF 48 PATIENTS OUT OF 102 UNDERWENT COMBINED PROCEDURES OF TRANSBRONCHIAL FORCEPS BIOPSY (TBFB) AND TBCB. DIAGNOSTIC VALUES AND SAFETY OUTCOMES OF TBFB AND TBCB WERE ANALYSED. THE SENSITIVITY, SPECIFICITY, POSITIVE PREDICTIVE VALUE (PPV), NEGATIVE PREDICTIVE VALUE (NPV) AND ACCURACY WERE 72.9%, 100%, 100%, 7.7%, AND 88.0% FOR TBFB, 85.1%, 100%, 100%, 12.5%, AND 93% FOR TBCB, AS WELL AS 91.5%, 100%, 100%, 20.0% AND 96.7% FOR THE COMBINED PROCEDURES, RESPECTIVELY, WITH A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14167255 ↗
• InjuryJun 15, 2021Material Twisted/Bent

  CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 19-MAY-2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pneumothorax

  MAUDE report 11999861 ↗
• InjuryJun 15, 2021Material Twisted/Bent; Material Twisted/Bent

  IT IS REPORTED DURING A SPIRATION VALVE PROCEDURE FOR BRONCHOSCOPIC LUNG VOLUME REDUCTION (INDICATION: EMPHYSEMA) USING A DISPOSABLE BALLOON CATHETER, THE DISTAL TIP OF CATHETER WAS NOTICEABLY BENT WHEN IN VIEW THROUGH WORKING CHANNEL OF SCOPE. THE BEND DID NOT ALLOW PROPER NAVIGATION IN LEFT UPPER LOBE FOR ACCURATE SIZING. BALLOON WAS TAKEN OUT AND REPLACED WITH A NEW ONE. THE PATIENT EXPERIENCED ALMOST IMMEDIATE ATELECTASIS OF THE LEFT UPPER LOBE AND PNEUMOTHORAX. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR) FOR CHEST TUBE PLACEMENT, AND THEN TO THE INTENSIVE CARE UNIT (ICU). THERE WERE NO REPORTED CHALLENGES WITH THE PATIENT'S ANATOMY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE GOOD WITH IMPROVEMENT IN HIS BREATHING AT HOME WITH DAILY EXERCISES.

  Patient problems: Pneumothorax

  MAUDE report 11999855 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT THE DEVICE (BALLOON CATHETER) WAS USED DURING A SPIRATION VALVE PROCEDURE. THE DOCTOR AT THE USER FACILITY REPORTED THE SPIRATION VALVES WERE PLACED IN THE PATIENT'S LEFT LUNG AND APPROXIMATELY 5 MINUTES AFTER EXTUBATION, THE PATIENT DEVELOPED A COUGH THAT COULD NOT RELIEVED BY A NEBULIZER. A CHEST X-RAY REVEALED THE PATIENT DEVELOPED A PNEUMOTHORAX IN THE LEFT UPPER LOBE. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED, THE SPIRATION VALVES WERE NOT REMOVED. THE PATIENT WAS HOSPITALIZED FOR TWO WEEKS AND THEN DISCHARGED TO HOME. ADDITIONALLY, THE DEVICES WERE INSPECTED PRIOR TO PROCEDURE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Pneumothorax

  MAUDE report 9593329 ↗
• InjuryJan 15, 2020Defective Device

  THE SERVICE CENTER WAS INFORMED THAT THE DEVICE (BALLOON CATHETER) WAS USED DURING A SPIRATION VALVE PROCEDURE. THE DOCTOR AT THE USER FACILITY REPORTED THE SPIRATION VALVES WERE PLACED IN THE PATIENT'S LEFT LUNG APPROXIMATELY 5 MINUTES AFTER EXTUBATION, THE PATIENT DEVELOPED A COUGH THAT WAS NOT RELIEVED BY A NEBULIZER. A CHEST X-RAY REVEALED THE PATIENT DEVELOPED A PNEUMOTHORAX IN THE LEFT UPPER LOBE. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED, THE SPIRATION VALVES WERE NOT REMOVED. THE PATIENT WAS HOSPITALIZED FOR TWO WEEKS AND THEN DISCHARGED TO HOME. ADDITIONALLY, THE DEVICES WERE INSPECTED PRIOR TO PROCEDURE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. THE REFERENCED DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. PNEUMOTHORAX IS A DOCUMENTED POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE SPIRATION VALVE SYSTEM.

  Patient problems: Pneumothorax

  MAUDE report 9593041 ↗
• MalfunctionJul 3, 2019Break; Break

  DURING A FOREIGN BODY REMOVAL PROCESS, THE SUBJECT DEVICE WAS USED. THE END OF THE BALLOON CATHETER RUPTURED AND FELL INTO THE TRACHEA. THE USER REPLACED ANOTHER BALLOON CATHETER TO REMOVE THE BROKEN PART AND THE FOREIGN BODY. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FALLING OF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761528 ↗