ChameleonRecalls & reported problems across all models

We found 7 models of Chameleon by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2022 and Aug 6, 2024 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Chameleon recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 19, 2024Open, Classified

   Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

   Z-0257-2025 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗

2. Dec 17, 2021Open, Classified

   The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.

   Z-0557-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Chameleon problems

Chameleon models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Chameleon CH08-40-75US

  Catheter, continuous flush
  2 recalls4 reports
• Chameleon CH07-40-75US

  Catheter, continuous flush
  1 recall6 reports
• Chameleon CH12-40-75US

  Catheter, continuous flush
  1 recall5 reports
• Chameleon CH10-40-75US

  Catheter, angioplasty, peripheral, transluminal
  1 recall3 reports
• Chameleon CH06-40-75US

  Catheter, Angioplasty, Peripheral, Transluminal
  1 recall2 reports
• Chameleon CH05-40-75US

  Catheter, continuous flush
  1 recall1 report
• Chameleon CH09-40-75US

  Catheter, angioplasty, peripheral, transluminal
  1 recall0 reports

Recent Chameleon adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Detachment of Device or Device Component; Infusion or Flow Problem; Detachment of Device or Device Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE ON A PATIENT WITH A STENOSIS IN THE LAUNCH AREA OF THE GRAFT, THE PHYSICIAN FOUND RESISTANCE WHILE INJECTING CONTRAST MEDIA FROM THE THIRD PORT AND REMOVED THE WIRE TO COMPLETE THE INJECTION. WHEN THEY REINSERTED THE WIRE AND TRIED TO REMOVE THE CATHETER, THE BALLOON WAS DETACHED. THEY FOUND IT ATTACHED TO THE WIRE. THE DETACHMENT WAS SPONTANEOUS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. AN INTRODUCER SHEATH WAS USED. A 0.035 GUIDE WIRE WAS USED. FLUSHING WAS NOT PERFORMED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. SALINE AND CONTRAST WERE THE INFLATION FLUIDS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. A SNARE WAS USED AS AN INTERVENTION TO RETRIEVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917891 ↗
• InjuryJun 19, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ACCORDING TO THE REPORTER, THE BALLOON CAME APART WITH A SECTION LODGED IN A PATIENT¿S ARTERY.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19571045 ↗
• InjuryMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT CAME IN NEEDING A CATHETER EXCHANGE IN THE RIJ (RIGHT INTERNAL JUGULAR VEIN). STENOSIS OF THE VENOTOMY SITE AND THE RIJ TUNNEL WAS SEEN. THE PREVIOUS CATHETER WAS REMOVED, AND A GUIDEWIRE WAS PLACED INTO THE RIJ (RIGHT INTERNAL JUGULAR). A 10X4 PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) BALLOON WAS THEN PLACED OVER THE WIRE AND INTO THE RIJ, WHERE ANGIOPLASTY WAS DONE AT BOTH THE VENOTOMY SITE AND DOWN THE RIJ. AFTER ANGIOPLASTY, THE PTA BALLOON WAS REMOVED, AND A 23-CM (CENTIMETER) COMPETITOR'S HEMODIALYSIS CATHETER WAS ATTEMPTED TO BE INSERTED OVER THE WIRE AND INTO THE PATIENT. THE DIALYSIS CATHETER GOT PAST THE VENOTOMY SITE BUT MET RESISTANCE (STENOSIS) AS IT CONTINUED DOWN RIJ. AT THAT TIME, THE DECISION WAS MADE TO DO MORE ANGIOPLASTY, SO THE DIALYSIS CATHETER WAS REMOVED, AND THE PTA BALLOON WAS PLACED BACK OVER THE WIRE AND DOWN THE RIJ, WHERE ADDITIONAL ANGIOPLASTY OF THE SVA (SUPERFICIAL VENOUS ARTERIALIZATION) AND RIJ WAS PERFORMED USING A 10 MM (MILLIMETER) BALLOON. UPON THE FINAL ANGIOPLASTY, THE BALLOON WAS STILL PARTIALLY INFLATED (THE BALLOON WAS PARTIALLY INFLATED AND PULLED BACK TOWARD THE VENOTOMY SITE INTENTIONALLY BY THE

  Patient problems: Arrhythmia; Discomfort; Foreign Body In Patient; Pain; Unintended Radiation Exposure

  MAUDE report 19305184 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NURSE WENT TO OPEN THE BALLOON AND IT WAS SNAPPED IN HALF. THE BALLOON NEVER TOUCHED THE PATIENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING ELSE UNUSUAL OBSERVED ON THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO DAMAGE TO THE DEVICE'S PACKAGING AND TO THE DEVICE'S BOX. THE PRODUCT WAS REPLACED WITH DIFFERENT LOT THREE DAYS AFTER THE INCIDENT AND THIS RESOLVED THE ISSUE BUT THEY STILL HAVE SOME OF THESE LOTS NUMBERS ON THEIR SHELF. THERE WERE NO CONFIRMED ISSUES OBSERVED WITH THESE REMAINING LOT NUMBERS ON THEIR SHELF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264486 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A 7MMX40MM BALLOON CATHETER WAS UNABLE TO BE REMOVED THROUGH A 6 FR. (FRENCH) SHEATH. THE BALLOON DETACHED FROM THE CATHETER AND WAS STUCK IN THE SHEATH WHEN TRYING TO BE REMOVED FROM THE PATIENT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932815 ↗
• MalfunctionJan 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE RIGHT FOREARM AVF (ARTERIOVENOUS FISTULA). THE CATHETER WAS USED TO TREAT STENOSIS OF THE INNOMINATE VEIN (90% OCCLUDED), THE SVC (SUPERIOR VENA CAVA) (70% OCCLUDED) AND THE CEPHALIC VEIN (70% OCCLUDED). THE BALLOON WAS INFLATED THREE TIMES TO 8 ATMS, ONCE IN EACH AREA LISTED ABOVE. UPON REMOVAL OF THE BALLOON FROM THE PATIENT VEIN, IT GOT STUCK AND BROKE IN THE SHEATH. THERE WERE NO ISSUES WITH PRIOR WITH INFLATING AND DEFLATING THE BALLOON. INFLATION DEVICE FROM COMPETITOR WAS USED TO INFLATE THE BALLOON. THE BALLOON WAS DETACHED FROM THE CATHETER UPON REMOVAL, AND IT WAS STUCK INSIDE THE SHEATH. THE CUSTOMER USED A COMPETITOR'S SHEATH WITH INT .035 GUIDEWIRE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO SIGNIFICANT FORCED WAS USED PER THE CUSTOMER. NO STENT WAS USED TO PASS THE DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591561 ↗
• MalfunctionJan 12, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT WAS PRESENTED WITH A NARROWING IN UPPER PORTION OF BRACHIAL VEIN MEDIAL TO A COVERED STENT. THE DOCTOR GAINED INITIAL ACCESS VIA A MICRO PUNCTURE SET, WHERE THE DOCTOR THEN PLACED AN ANGIOCATH FOR INITIAL IMAGING. PROPER FLUSHING PERFORMED OF SHEATH, GUIDEWIRE, AND CATHETER PRIOR TO CASE WITH NORMAL RESULT. ONCE THE LESION WAS IMAGED, A 7FR (FRENCH) COMPETITOR¿S SHEATH WAS INTRODUCED OVER THE WIRE FOLLOWED BY A 10X40 CHAMELEON BALLOON. THE BALLOON WAS ADVANCED TO THE AREA OF STENOSIS AND INFLATED TO RBP (RATED BURST PRESSURE) OF 14. BALLOON WAS THEN RETRACTED TO THE AREA AT THE MEDIAL ENDPOINT OF THE STENT AND ANGIOPLASTY WAS PERFORMED IN A SECOND AREA USING INFLATION DEVICE TO THE RBP. BALLOON WAS DEFLATED AFTER 60 SECONDS, AND IMAGING WAS PERFORMED TO DETERMINE THAT THERE WAS NO RESIDUAL STENOSIS POST ANGIOPLASTY. THE DOCTOR WENT TO REMOVE THE BALLOON AND AS THE DOCTOR PULLED THROUGH THE SHEATH, THE DOCTOR RECEIVED RESISTANCE. THE DOCTOR WAS ABLE TO PULL AGAIN BUT THE RESISTANCE INCREASED AND AT THIS POINT, THE DOCTOR KNEW THAT AT LEAST A PORTION OF THE BALLOON WAS INSIDE THE SHEATH. THE DOCTOR PULLED AGAIN, AND THE BALLOON SEPARATED FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503897 ↗
• MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS PULLED OUT OF THE PACKAGING, THE CATHETER SHAFT HAD SPLIT INTO TWO PIECES. THERE WAS NO OBVIOUS DAMAGE TO THE PACKAGING AND/OR THE CATHETER BEFOREHAND. THE DEVICE'S BOX CAME IN INTACT AND THE STERILE BARRIER WAS INTACT. BESIDES THE REPORTED ISSUE, THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DIFFICULTY WHEN PULLING THE DEVICE OUT OF THE PACKAGING. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE, AND THE DETACHMENT WAS SEEMINGLY SPONTANEOUS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TO RESOLVE THE ISSUE, A NEW PRODUCT WAS PROVIDED TO THE CUSTOMER FROM THE TRUNK STOCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302504 ↗
• MalfunctionNov 9, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PROVIDER WAS ATTEMPTING TO REMOVE THE BALLOON FROM THE 6FR SHEATH (MERIT PRELUDE), AND THE BALLOON BECAME STUCK. THE PROVIDER CONTINUED TO PULL, AND THE BALLOON SHAFT STRETCHED TO THE POINT OF BREAKING, LEAVING THE BALLOON IN THE SHEATH IN COMPLETE DISCONNECTION OF THE CATHETER INTO TWO SEPARATE PIECES AND WAS LEFT INSIDE THE SHEATH. THERE WERE NO PIECES FELL IN THE PATIENT'S BODY. IT WAS ALSO STATED THAT THE ISSUE ENCOUNTERED AFTER BALLOON INFLATION, BALLOON WAS FULLY DEFLATED AND WAS DETACHED FROM THE CATHETER. THE BALLOON WAS INFLATED USING INFLATION DEVICE ¿BARD PRESTO¿. THERE WAS NO LEAK AND NO ISSUE WITH THE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVE ON THE PRODUCT PRIOR TO USE AND THEREWERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE PRODUCT AND THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONEWITH NO ISSUES IDENTIFIED. THE SHEATH AND BALLOON WERE REMOVED TOGETHER AS REMEDIAL ACTION, AND NEW SHEATH AND DIFFERENT BALLOON WERE PLACED AT SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107158 ↗
• MalfunctionOct 3, 2023Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  ACCORDING TO THE REPORTER, THE FIRST TIME THE DEVICE WAS USED AT A NOMINAL VALUE OF 16 ATMOSPHERIC PRESSURE, AND THE SECOND TIME IT WAS USED AT 22 ATMOSPHERES, AND AFTER INFLATING THE BALLOON IN THE PATIENT, THE BALLOON RUPTURED DUE TO A LONGITUDINAL CRACK AFTER 20 SECONDS. IT WAS NOTICED THAT THE PRESSURE HAD DECREASED. THERE WAS NO LEAK. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER PARTICULAR DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO PARTICULAR PRODUCTS UTILIZED WITH THE DEVICE. IT WAS STATED THAT 6 FRENCH (FR) AND 11 CENTIMETERS (CM) OF COMPETITOR'S INTRODUCER SHEATH WAS USED, AND A 0.035 COMPETITOR'S GUIDEWIRE WAS USED. AN UNKNOWN INFLATOR WAS USED TO INFLATE THE BALLOON, AND THE INFLATION FLUID USED COULD NOT BE CONFIRMED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT COULD NOT BE CONFIRMED IF THERE WAS RESISTANCE ENCOUNTERED WHEN THE DEVICE WAS ADVANCED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE BALLOON HAD BEEN COLLECTED. IT WAS ONLY A RUPTURE AND DID NOT BECOME A PIECE. THE BALLOON WAS REMOVED WHEN IT WAS PULLED OUT WITH THE SHEATH I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865726 ↗
• MalfunctionSep 7, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING THE FIRST INFLATION AT 2 ATM (ATMOSPHERE),THE BALLOON BURST LONGITUDINALLY. THE BALLOON LOOKED AND ACTED NORMAL PRIOR TO INFLATION. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PRODUCT SEPARATED INTO TWO OR MULTIPLE SEPARATE PIECES. HOWEVER, ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ASSUMED A 6FR INTRODUCER SHEATH WAS USED. NO EXCESSIVE FORCE WAS USED. THE CATHETER WAS NOT REPAIRED. SALINE AND CONTRAST MIX WAS THE CLEANING AGENTS USED ON THE DEVICE. THE BALLOON WAS INFLATED BY INFLATION DEVICE (MAKE AND MODEL) BARD PRESTO. FLUSHING WAS PERFORMED PER INSTRUCTION PER USE, AND NO ISSUES WERE IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WERE NO ADDITIONAL TREATMENTS OR INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. A DIFFERENT BALLOON WAS USED AS A REMEDIAL ACTION TO FINISH THE CASE. THE PROCEDURE WAS COMPLETED. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701948 ↗
• MalfunctionJul 27, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  ACCORDING TO THE REPORTER, WHEN THE CONTRAST MEDIUM WAS INJECTED THROUGH THE INJECTION PORT, THE CONTRAST MEDIUM LEAKED FROM A PORTION OTHER THAN THE DRAINAGE HOLE. THERE WAS A LEAK AT THE CATHETER SHAFT. THERE WAS NO LUER ADAPTER PROBLEM. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. TEGO WAS NOT UTILIZED, AND THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. INTERVENTION/TREATMENT WAS NOT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION THE CATHETER WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS RELATED TO THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. MOZARC PERFORMED AN EVALUATION OF THE REPORTED CATHETER AND THE INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT VISUAL INSPECTION OF THE DEVICE NOTED THAT THERE WAS A CRACK ON THE LUER PORT FOR THE CONTRAST MEDIA. THE CRACK LEAKED WHEN THE PORT WAS FLUSHED WITH WATER. THE PACKAGING WAS NOT RETURNED, SO THE ROOT CAUSE OF THE OBSERVED DAMAGE COULD NOT BE RELIABLY DETERMINED, HOWEVER ALL DEVICES ARE TESTED FOR LE AKS BEFORE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402805 ↗
• MalfunctionJun 30, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FIRST BALLOON (SIZE 12MILLIMETERX40MMX75CENTIMETER) WAS DEFLATED AND BECAME HUNG UP IN AN INTRODUCER SHEATH AND ACTUALLY SHEARED OFF (UNCERTAIN IF COMPLETELY DETACHED) ABOUT 1.5 INCHES ABOVE THE SHEATH. THEY HAD TO USE ANOTHER INTRODUCER SHEATH TO FISH IT OUT. THE OTHER BALLOON (SIZE 10X4) WAS WORKING FINE AND THEN TAKEN OUT OF THE PATIENT DURING A DECLOT CASE. WHEN THE BALLOON WAS REINSERTED, THE BALLOON WAS NOT ABLE TO OPEN ONCE INSIDE THE PATIENT. THEY REMOVED THE BALLOON AND IT APPEARED THAT PART OF THE BALLOON WAS GETTING HUNG UP ON ITSELF ON THE INJECTION PORT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER CONNECTOR ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. INTRODUCER SHEATH (FRENCH 7), CONTRAST, SALINE AND 0.35 GUIDEWIRE WERE UTILIZED WITH THE DEVICE. FLUSHING WAS DONE AS PER IFU (INSTRUCTION FOR USE) AND HAD A NORMAL/GOOD OUTCOME. THERE WAS NO REPORTED CLEANING AGENT USED ON THE DEVICE. THE BALLOON WAS INFLATED USING A SYRINGE AND STANDARD INFLATION FLUID WAS USED. A MAXIMUM INFLATION PRESSURE WAS APPLIED WHEN IT WAS DETERMINED THAT THERE WAS INFLATION DIFFICULTIES. THE DEVICE PASSED THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240871 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, WHEN ADVANCING THE DEVICE ON FIRST ATTEMPT, RESISTANCE ENCOUNTERED. AFTER FIRST INFLATION UP TO 14 ATMS ( ATMOSPHERE), THE PRODUCT'S BALLOON HAD BURST BEFORE THE RATED BURST PRESSURE WAS REACHED, HAD TORN AND WAS TEARING AT THE CONNECTION SITE NEXT TO WHERE THE SILVER PORT OPENING WAS (ON THE FRONT END OF THE BALLOON) BUT THE BALLOON DID NOT COMPLETELY SEPARATE FROM THE SHAFT AND NO PORTION OF DEVICE FELL IN PATIENT. THE CONNECTION ISSUE WAS AT THE SILVER PORT AND BALLOON. THE BACK END ¿HUB¿ WAS FINE. 7 FR COMPETITOR'S INTRODUCER SHEATH WAS USED. THE SIZE OF GUIDEWIRE WAS .035. THERE WAS NO ISSUE WITH THE HUB OR LUER. NO EXCESSIVE FORCE USED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE BALLOON WAS INFLATED BY INFLATION DEVICE. FLUSHING WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO CLEANING AGENT USED ON THE DEVICE. THEY REMOVED OR PULLED OUT THE PRODUCT FROM PATIENT THROUGH THE SHEATH BEFORE TOO MUCH BLOOD LOSS AS REMEDIAL ACTION TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH COMPETITOR'S BALLOON. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TR

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237639 ↗
• MalfunctionJun 29, 2023Burst Container or Vessel; Material Integrity Problem; Positioning Problem; Burst Container or Vessel; Material Integrity Problem; Positioning Problem

  ACCORDING TO THE REPORTER, WHEN ADVANCING THE DEVICE ON FIRST ATTEMPT, RESISTANCE ENCOUNTERED. AFTER FIRST INFLATION UP TO 14 ATMS ( ATMOSPHERE), THE PRODUCT'S BALLOON HAD BURST, HAD TORN BUT THE BALLOON DID NOT COMPLETELY SEPARATE FROM THE SHAFT AND NO PORTION OF DEVICE FELL IN PATIENT. IT WAS ALSO STATED THAT THE LUER CONNECTOR WAS WEAK AND HAD TORN. 7 FR COMPETITOR'S INTRODUCER SHEATH WAS USED. THE SIZE OF GUIDEWIRE WAS .035. NO EXCESSIVE FORCE USED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE BALLOON WAS INFLATED BY INFLATION DEVICE. FLUSHING WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO CLEANING AGENT USED ON THE DEVICE. THEY REMOVED OR PULLED OUT THE PRODUCT FROM PATIENT THROUGH THE SHEATH BEFORE TOO MUCH BLOOD LOSS AS REMEDIAL ACTION TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH COMPETITOR'S BALLOON. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO ADDITIONAL TREATMENTS/INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227647 ↗

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