MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number TXR-8.5-12-15-A

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2023

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook tri-ex extraction balloon with multiple sizing.It was reported, [that the] user detected the balloon rupture during stone removal.User then changed to another brand of similar device to complete the procedure.We received device pictures for evaluation.It was noted, possible balloon piece was missing.The initial reporter stated, that a section of the device did not remain inside the patient¿s body.However, the location of the possible missing section observed during our laboratory evaluation of the photo is unknown.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.

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the photos and video provided in response to this report, because the product said to be involved was not provided to cook for evaluation.Per the photos provided, we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed.Based solely on the photos and statements describing the event.Photo 1 shows; the open box with a label on it that matches the rpn/lot number from that in the report.Photo 2 shows; the deflated balloon in the pouch in a coiled position with the syringe.Photo 3 shows; the distal tip of the balloon.The balloon material is ruptured and there appears to potentially be portions of the balloon material missing, confirming the complaint.The video shows the balloon being inflated with the syringe.And the balloon deflates quickly.The device history record for the lot # said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately, prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes, production personnel were notified.Investigation conclusion: our evaluation of the photos provided confirmed the report; however, 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.In the information provided in the report, it states the balloon was not tested prior to use.The ifu states: "verify balloon integrity prior to use by attaching the enclosed syringe to the stopcock and inflating the balloon with air only.If any leakage is detected, do not use." a pinhole, split, or rupture in the balloon can occur if the balloon material has come into contact with a sharp object, such as a sharp stone or possibly a burr in the endoscope channel.A split or rupture in the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to "gently withdraw the inflated balloon toward the papilla." the instructions for use contain the following: ¿warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.¿ prior to distribution, all tri-ex extraction balloon with multiple sizing are subjected to a visual inspection and functional testing 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: 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.Additional comments regarding this report: based on the information provided that the balloon was not tested prior to use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

This correction follow up report is being sent to cancel the initial report submitted relating to this event.Please reference the additional manufacturer narrative notes section h10 for this justification.

Manufacturer Narrative

An emdr report was initially sent on 06/01/2023, based on the information that possible ruptured balloon piece was missing.This was reported out of caution due to the appearance of the provided photo from the user.The device was received for evaluation on 06/06/2023 where it was determined that no portion of the ruptured balloon is missing.A ruptured extraction balloon that has no missing material has not historically caused or contributed to a serious injury or death.Therefore, this is no longer considered reportable.This emdr cancels the initial emdr.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 17038051
• MDR Text Key: 316434987
• Report Number: 1037905-2023-00265
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002268569
• UDI-Public: (01)10827002268569(17)230830(10)W4632048
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4632048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL
• Patient Age: 65 YR
• Patient Sex: Male