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

Catalog Number FS-QEB-XL-A

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/26/2015

Event Type  malfunction  

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 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.The instructions for use state, "visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use." 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 endoscopy procedure, the physician used a cook fusion quattro extraction balloon.The customer claimed that the little black rings (radiopaque bands) at the tip (near the balloon) broke off.The bands did not get in the bile duct and will pass through the patient.Another device was used to complete the procedure.Other than the radiopaque bands left to pass naturally, a section of the device did remain inside the patient's body.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

Initially, the following information was provided to cook: during an endoscopy procedure, the physician used a cook fusion quattro extraction balloon.The customer claimed that the little black rings [radiopaque bands] at the tip (near the balloon) broke off.The bands did not get in the bile duct and will pass through the patient.An initial mdr was submitted on 7/23/2015 based on this information.When the device was received for evaluation on 7/31/2015, we confirmed the biocompatible ink markings were damaged and portions of the ink markings are missing from the distal end of the device.All the radiopaque bands were present and in the correct location on the distal end of the device.Based on the device evaluation, this incident no longer meets the reporting criteria of an fda mdr report.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd. ; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4945781
• MDR Text Key: 22407341
• Report Number: 1037905-2015-00305
• Device Sequence Number: 1
• Product Code: GCA
• 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: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2016
• Device Catalogue Number: FS-QEB-XL-A
• Device Lot Number: W3564689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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