BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR

    MDR report key: 1910553 · Received November 19, 2010

    Report

    Report Number
    1037905-2010-00631
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 20, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(4). ADDITIONAL INFORMATION: EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. DAMAGE TO THE BALLOON CATHETER COULD HAVE OCCURRED IF THE BALLOON DILATOR RECEIVED EXCESSIVE PRESSURE DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE AND/OR GENERAL HANDLING. A POSSIBLE CONTRIBUTING FACTOR IS INADEQUATE LUBRICATION OF THE BALLOON WITH A WATER SOLUBLE LUBRICANT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY TO MAINTAIN BALLOON DEFLATION. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. DIFFICULTY WITH BALLOON DEFLATION AND REMOVAL FROM THE ENDOSCOPE CAN OCCUR IF THE BALLOON CATHETER IS COMPROMISED. FOR EXAMPLE, IF THE BALLOON DILATOR CATHETER HAS A VOID SUCH AS A SPLIT, FULL BALLOON DEFLATION MAY BE PROHIBITED. INCOMPLETE BALLOON DEFLATION COULD CREATE DIFFICULTY IN REMOVING THE BALLOON FROM THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: "A COMPROMISED BALLOON MAY PROHIBIT REMOVAL FROM THE ENDOSCOPE ACCESSORY CHANNEL. REMOVAL OF THE ENDOSCOPE ALONG WITH THE COMPROMISED BALLOON MAY BE REQUIRED." PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIRE GUIDED BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK ENDOSCOPY HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR. THE CATHETER SPLIT CAUSING LEAKAGE. THE BALLOON WAS ABLE TO BE INFLATED BUT NOT COMPLETELY. DIFFICULTY WAS ENCOUNTERED DURING DEFLATION OF THE BALLOON DUE TO THE SPLIT IN THE CATHETER. A SECTION OF THE BALLOON CATHETER REMAINED INSIDE THE PATIENT. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SECTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. OTHER THAN WHAT IS DESCRIBED ABOVE, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY W2873201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)| ALLIANCE INFLATION DEVICE