MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER FLEXIMA¿ NASOBILIARY CATHETER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00540120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima¿ nasobiliary catheter was used in the common bile duct during an endoscopic nasobiliary drainage (enbd) placement performed on (b)(6) 2017.According to the complainant, during preparation, while removing the working length of catheter from the holder, the catheter got separated from the joint of the rigid part.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Investigation result: a visual evaluation of the returned device found the catheter was found separated/torn at bonded area.Kinks were noted on multiple location of the catheter.Based on the available information, it is most likely that handling and device manipulation during preparation may have contributed to the separation and kinking of the catheter.Therefore the most probable root cause of this complaint is handling damage.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a flexima¿ nasobiliary catheter was used in the common bile duct during an endoscopic nasobiliary drainage (enbd) placement performed on (b)(6) 2017.According to the complainant, during preparation, while removing the working length of catheter from the holder, the catheter got separated from the joint of the rigid part.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIMA¿ NASOBILIARY CATHETER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6392973
• Report Number: 3005099803-2017-00693
• Device Sequence Number: 443038
• Product Code: FGE
• UDI-Device Identifier: 08714729337386
• UDI-Public: (01)08714729337386(17)20190831(10)19596208
• Combination Product (Y/N): N
• PMA/510(K) Number: K982508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: M00540120
• Device Catalogue Number: 4012
• Device Lot Number: 19596208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1