MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection of the returned device determined that the balloon material was ruptured.Most of the balloon material is missing and not all of the ruptured material matches up from side to side.Due to the condition of the balloon material a functional test could not be performed.The threads on the proximal and distal end of the balloon appear to be manufactured correctly.The pre-packaged syringe was included in the return.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The information provided indicated the balloon inflated properly prior to use.Therefore, the balloon was intact and functioning prior to advancement through the endoscope.A split or rupture in the balloon material can occur if the balloon 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 quattro extraction balloons 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), the physician used a cook fusion quattro extraction balloon.Upon extracting stones from the bile duct, the balloon snapped (ruptured).There was no reportable information at this time.The device was received for evaluation on (b)(6) 2019.Our evaluation of the returned device determined that there were pieces of the balloon material missing and were not included in the return of the device.This information was communicated to the user facility and the location of the missing pieces was unknown.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation 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.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• 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: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8388130
• MDR Text Key: 141340799
• Report Number: 1037905-2019-00104
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002482258
• UDI-Public: (01)00827002482258(17)190910(10)W4117928
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2019
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W4117928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• 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