MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00539310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr.Report # 3005099803-2019-04575).It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the biliary duct, performed on (b)(6) 2019.According to the complainant, during the procedure while the physician attempted to release the stent, the suture released properly but it failed to deploy.The device was noted to be 'damaged'.Cannulation was performed and another attempt was made using a new flexima biliary stent however, the same problem occurred.Finally, a third flexima biliary stent was used, yet the stent failed to deploy.The procedure was completed using a fourth biliary stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed the proximal end of the guide catheter was detached while the rest of the guide catheter appeared to have remained within the push catheter.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9056450
• Report Number: 3005099803-2019-04574
• Device Sequence Number: 1784771
• Product Code: FGE
• UDI-Device Identifier: 08714729162629
• UDI-Public: 08714729162629
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K965147
• 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
• Report Date (Section B): 09/13/2019

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: 03/20/2021
• Device Model Number: M00539310
• Device Catalogue Number: 3931
• Device Lot Number: 0021889038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 71