BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM TTC BILIARY BALLOON DILATOR

    MDR report key: 9655590 · Received January 31, 2020

    Report

    Report Number
    1037905-2020-00052
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 7, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K171223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WANG, D, JI, J., ET AL. (2015). EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY AS RESCUE FOR A BALLOON DILATOR TRAPPED IN THE PANCREATIC DUCT. ENDOSCOPE 2015, 47; E604-E606. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PHOTOS WERE INCLUDED AND EVALUATED. AN EVALUATION OF THE PHOTOS PROVIDED IN THE CLINICAL LITERATURE ARTICLE CONFIRMED THE REPORT. FIGURE 4 SHOWS IMAGES OF THE PROXIMAL END OF THE DEVICE. FIGURE 6 IN THE ATTACHED ARTICLE SHOWS A DAMAGED AND DISTORTED BALLOON; HOWEVER, IT CANNOT BE DETERMINED WHAT CAUSED THE DAMAGE TO OCCUR. WITHOUT RETURN OF THE COMPLAINT DEVICE A COMPLETE EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE INFORMATION PROVIDED INDICATED THAT THE BALLOON WAS USED TO DILATE A PANCREATIC STRICTURE. THIS AREA IS NOT INTENDED FOR THE USE OF THIS DEVICE AND THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. THE INTENDED USE IN THE INSTRUCTIONS FOR USE STATES: "THIS DEVICE IS USED TO DILATE STRICTURES OF THE BILIARY TREE." PRIOR TO DISTRIBUTION, ALL QUANTUM TTC BILIARY BALLOON DILATORS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN A CASE REPORT REGARDING A COOK QUANTUM TTC BILIARY BALLOON DILATOR: "FOLLOWING SPHINCTEROTOMY, A BALLOON DILATOR WITH A DIAMETER OF 8MM AND LENGTH OF 3 CM (QUANTUM TTC; WILSON-COOK MEDICAL, WINSTON-SALEM, NORTH CAROLINA, USA) WAS USED TO DILATE THE STRICTURE. HOWEVER, THE STONE FRAGMENTS PUNCTURED AND BROKE THE BALLOON. WHEN WE TRIED TO PULL OUT THE BALLOON DILATOR, WE ENCOUNTERED A HIGH DEGREE OF RESISTANCE AND FAILED TO REMOVE IT. ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) SHOWED THAT THE TWO MARKERS ON THE BALLOON DILATOR WERE CLOSER TOGETHER THAN NORMAL, INDICATING THAT THE BALLOON WAS FOLDED AND TRAPPED IN THE MAIN PANCREATIC DUCT.THE PLUNGER HANDLE OF THE BALLOON DILATOR WAS THEN CUT OFF, AND THE DUODENOSCOPE WAS WITHDRAWN. WE TRIED TO INSERT A GUIDEWIRE BESIDE THE DISTORTED BALLOON WITH THE DUODENOSCOPE, BUT IT INEVITABLY SLIPPED INTO A BRANCH OF THE PANCREATIC DUCT WITHOUT PASSING THE TRAPPED BALLOON. THE DUODENOSCOPE WAS AGAIN WITH-DRAWN. THE BALLOON CATHETER WAS EXTRACTED THROUGH THE NASAL CAVITY AND CONNECTED TO A TUOHY¿BORST CONNECTOR AS A NASOPANCREATIC TUBE. TO RELEASE THE TRAPPED BALLOON, ANOTHER EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) PROCEDURE WAS PERFORMED TO BREAK UP THE IMPACTED STONES INTO SMALLER PIECES, TARGETING THE STONES AROUND THE TWO MARKERS. AT 48 HOURS AFTER THE SECOND ESWL, A SECOND ERP WAS PER-FORMED. A GUIDE WIRE M (RADIFOCUS; TERUMO CORPORATION, TOKYO, JAPAN) AND A 6-FR PLASTIC BOUGIE DILATOR WERE INSERTED, BUT THE LATTER COULD NOT PASS THROUGH THE STRICTURE. THE PLASTIC BOUGIE DILATOR WAS USED AS A SUPPORT WHILE THE GUIDE WIRE WAS RE-PLACED WITH A STANDARD GUIDEWIRE, AND THE PANCREATIC DUCT WAS THEN DILATED WITH A STENT RETRIEVER (SOEHENDRA; WILSON-COOK MEDICAL) AND MULTILEVEL PLASTIC BOUGIE DILATORS. FINALLY, A BALLOON DILATION CATHETER WITH A DIAMETER OF 8MM AND LENGTH OF 4 CM (HURRICANE; BOSTON SCIENTIFIC, NATICK, MASSACHUSETTS, USA) WAS USED TO DILATE THE STRICTURE. THE BROKEN, FOLDED, AND DISTORTED BALLOON DILATOR WAS THEN PULLED OUT." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE BALLOON WAS RETRIEVED BY ESWL PROCEDURE AND SECOND ERP. IT WAS NOT REPORTED IN THE CASE REPORT IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    WANG, D, JI, J., ET AL. (2015). EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY AS RESCUE FOR A BALLOON DILATOR TRAPPED IN THE PANCREATIC DUCT. ENDOSCOPE 2015, 47; E604-E606. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN A CASE REPORT REGARDING A COOK QUANTUM TTC BILIARY BALLOON DILATOR: "FOLLOWING SPHINCTEROTOMY, A BALLOON DILATOR WITH A DIAMETER OF 8MM AND LENGTH OF 3 CM (QUANTUM TTC; WILSON-COOK MEDICAL, (B)(4), USA) WAS USED TO DILATE THE STRICTURE. HOWEVER, THE STONE FRAGMENTS PUNCTURED AND BROKE THE BALLOON. WHEN WE TRIED TO PULL OUT THE BALLOON DILATOR, WE ENCOUNTERED A HIGH DEGREE OF RESISTANCE AND FAILED TO REMOVE IT. ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) SHOWED THAT THE TWO MARKERS ON THE BALLOON DILATOR WERE CLOSER TOGETHER THAN NORMAL, INDICATING THAT THE BALLOON WAS FOLDED AND TRAPPED IN THE MAIN PANCREATIC DUCT. THE PLUNGER HANDLE OF THE BALLOON DILATOR WAS THEN CUT OFF, AND THE DUODENOSCOPE WAS WITHDRAWN. WE TRIED TO INSERT A GUIDEWIRE BESIDE THE DISTORTED BALLOON WITH THE DUODENOSCOPE, BUT IT INEVITABLY SLIPPED INTO A BRANCH OF THE PANCREATIC DUCT WITHOUT PASSING THE TRAPPED BALLOON. THE DUODENOSCOPE WAS AGAIN WITH-DRAWN. THE BALLOON CATHETER WAS EXTRACTED THROUGH THE NASAL CAVITY AND CONNECTED TO A TUOHY¿BORST CONNECTOR AS A NASOPANCREATIC TUBE. TO RELEASE THE TRAPPED BALLOON, ANOTHER EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) PROCEDURE WAS PERFORMED TO BREAK UP THE IMPACTED STONES INTO SMALLER PIECES, TARGETING THE STONES AROUND THE TWO MARKERS. AT 48 HOURS AFTER THE SECOND ESWL, A SECOND ERP WAS PER-FORMED. A GUIDE WIRE M (RADIFOCUS; TERUMO CORPORATION, (B)(4)) AND A 6-FR PLASTIC BOUGIE DILATOR WERE INSERTED, BUT THE LATTER COULD NOT PASS THROUGH THE STRICTURE. THE PLASTIC BOUGIE DILATOR WAS USED AS A SUPPORT WHILE THE GUIDE WIRE WAS RE-PLACED WITH A STANDARD GUIDEWIRE, AND THE PANCREATIC DUCT WAS THEN DILATED WITH A STENT RETRIEVER (SOEHENDRA; WILSON-COOK MEDICAL) AND MULTILEVEL PLASTIC BOUGIE DILATORS. FINALLY, A BALLOON DILATION CATHETER WITH A DIAMETER OF 8MM AND LENGTH OF 4 CM (HURRICANE; BOSTON SCIENTIFIC, (B)(4), USA) WAS USED TO DILATE THE STRICTURE. THE BROKEN, FOLDED, AND DISTORTED BALLOON DILATOR WAS THEN PULLED OUT." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE BALLOON WAS RETRIEVED BY ESWL PROCEDURE AND SECOND ERP. IT WAS NOT REPORTED IN THE CASE REPORT IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115706 QUANTUM TTC BILIARY BALLOON DILATOR FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ENDOSCOPE, UNKNOWN MAKE OR MODEL