MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING

Catalog Number FS-8.5-12-15-A

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product code and device name: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.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.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.The device history record contains a nonconformance for excessive glue, that could potentially be related to balloon material ruptures.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: 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 report it states that the balloon was tested prior to advancement down the endoscope accessory channel.The balloon did inflate properly prior to use.A balloon leakage 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.Prior to distribution, all fusion 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion extraction balloon with multiple sizing.It was reported that since the target stone was 10mm, eplbd [endoscopic papillary large balloon dilation] (12mm) was performed after est [endoscopic sphincterotomy].After crushing the stone with another manufacturer's basket, the complaint device was used to extract the remaining pieces of the crushed stone.However, the balloon ruptured at the 4th sweep when the piece was swept out through the papilla.Therefore, another manufacturer's basket was used instead to sweep the pieces to complete the procedure.A segment of the balloon (latex) remained inside the duodenum due to rupture, but there have been no adverse effects to the patient reported.The piece of the balloon remained inside the patient¿s body to pass naturally.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.

• Brand Name: FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING
• Manufacturer (Section D): COOK ENDOSCOPY; 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: 12798499
• MDR Text Key: 285223112
• Report Number: 1037905-2021-00623
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002315379
• UDI-Public: (01)10827002315379(17)220816(10)W4506018
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2022
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W4506018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: MICHISUJI 25, 0.025INCH/ BY KANEKA; OLYMPUS ENDOSCOPE, JF-260V