MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA¿ NASOBILIARY CATHETER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00540120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of tube detached.A visual evaluation of the returned nasobiliary catheter revealed the catheter was found separated/broken.The catheter was also noted to be kinked near the distal tip or pigtail section.The reported event of catheter separated was confirmed.Based on the information available it is possible that the way in which the device was handled and manipulated during preparation may have contributed to the failure noted, 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 other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was opened for used in the bile duct for an endoscopic nasobiliary drainage (enbd) procedure.According to the complainant, during preparation the connecting part of dark blue and pale blue tube in the working length got separated.The procedure was completed with another flexima nasobiliary catheter.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 - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6419221
• Report Number: 3005099803-2017-00713
• Device Sequence Number: 10772042
• Product Code: FGE
• UDI-Device Identifier: 08714729337386
• UDI-Public: (01)08714729337386(17)20190630(10)19358415
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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: 06/30/2019
• Device Model Number: M00540120
• Device Catalogue Number: 4012
• Device Lot Number: 19358415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1