MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570520
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of catheter difficult to remove.Investigation results: a wallflex biliary rx delivery system was returned for analysis, the fully deployed stent was not received.A visual examination of the returned device found that the delivery system was received fully deployed.No damages were noted to the inner shaft, outer sheath, or handle.It is not possible to confirm the complaint based on the condition of the returned device.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2016-03753 and 3005099803-2016-03752 for the associated device information.It was reported to boston scientific corporation on november 14, 2016 that two wallflex biliary rx covered stents were used during an endoscopic retrograde cholangiopancreatography performed on (b)(6) 2016.According to the complainant, during the procedure, the first stent ¿popped¿ during deployment (the subject of mfr report # 3005099803-2016-03753).The physician removed the first stent and successfully deployed a second wallflex biliary stent (the subject of mfr report # 3005099803-2016-03752); however, when the physician removed the delivery system, it also pulled the stent out of the patient.Attempts to obtain additional information regarding patient¿s condition has been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6156121
• Report Number: 3005099803-2016-03752
• Device Sequence Number: 10946413
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: (01)08714729764908(17)20180721(10)19503463
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2016

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: Health Professional
• Device Expiration Date: 07/21/2018
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 19503463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1