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

Catalog Number FS-QEB-A

Device Problems Detachment Of Device Component (1104); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

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.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The information provided from the user indicated the device was used for "balloon tamponade of fistula tract." this is against the intended use of the device which states "this device is used for endoscopic removal of stones in the biliary system and for contrast injection." the instructions for use also state "do not use this device for any purpose other than the stated intended use." this is the most likely cause for the reported observation.Prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 device was not use for its intended 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

During balloon tamponade of fistula tract, the physician used a cook fusion quattro extraction balloon.Per medwatch form ((b)(4)): "when attempting to remove the balloon by [gastrointestinal] gi, it was noticed that the balloon had broken off and could not be removed by hemostat.Since the balloon broke free from the apparatus which was maintaining inflation, it should no longer be inflated.Small, flexible catheter may well pass spontaneously per rectum.Doctor to follow patient with serial kubs-kidneys, ureters, and bladder.What was the originally intended procedure? balloon tamponade of fistula tract to stop bleeding of enterocutaneous fistula.Device usage problem: device malfunction - this, the device did not do what it was supposed to do.Device usage problem: device failed (e.G.Broke, could not get it to work or stopped working).".

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6962018
• MDR Text Key: 89735426
• Report Number: 1037905-2017-00646
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002482258
• UDI-Public: (01)00827002482258(17)180313(10)W3837340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017,10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2017
• Distributor Facility Aware Date: 06/05/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2017
• Date Device Manufactured: 03/13/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 45