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

Model Number	M00540120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nasobiliary catheter was opened for use during a endoscopic nasobiliary drainage (enbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation the catheter got detached when removed from the pouch.The procedure was completed with another nasobiliary catheter.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.  should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation results: a visual evaluation was performed of the returned flexima nasobiliary catheter found that the working length was broken from the distal tip (pig tail).It is possible that the way in which the device was handled and manipulated during unpacking or preparation may have contributed to the breaking of the catheter.During manufacturing the units are inspected in order to avoid the failures found.Most likely, the damages found are consistent with one caused when catheter is being pulled; this may cause damage, deformities or device break.Therefore, the most probable root cause assigned to the complaint is ¿handling damage.¿ a review of the device history record (dhr) was performed and no deviations were 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 nasobiliary catheter was opened for use during a endoscopic nasobiliary drainage (enbd) procedure performed on (b)(6) 2016.According to the complainant, during preparation the catheter got detached when removed from the pouch.The procedure was completed with another nasobiliary catheter.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 6191294
• Report Number: 3005099803-2016-03990
• Device Sequence Number: 439785
• Product Code: FGE
• UDI-Device Identifier: 08714729337386
• UDI-Public: (01)08714729337386(17)20190630(10)19334880
• 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,Followup
• Report Date (Section B): 11/30/2016

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: M00540120
• Device Catalogue Number: 4012
• Device Lot Number: 19334880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1