MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965431100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of catheter broken.The device has been received for analysis; however, 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary partially covered stent was to be used to treat a lesion due to cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the delivery system broke.The procedure was completed using a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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
A fully constrained wallstent biliary stent and delivery system was returned for analysis.Visual analysis of the returned device found that the blue outer sheath was detached from the valve body.An adhesive fillet was noted around the entire circumference of the valve body, indicating proper application of adhesive.The clear outer sheath was found to be curved.Functional examination found that it was possible to manually deploy the device by retracting the outer sheath without issue.No issues noted with the stent and no other issues were noted with the device.The noted damages to the returned device were likely due to anatomical or procedural factors, such as tight anatomy, encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary partially covered stent was to be used to treat a lesion due to cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the delivery system broke.The procedure was completed using a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7010405
• Report Number: 3005099803-2017-03397
• Device Sequence Number: 18994684
• Product Code: FGE
• UDI-Device Identifier: 08714729317937
• UDI-Public: 08714729317937
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 02/27/2019
• Device Model Number: H965431100
• Device Catalogue Number: 43110
• Device Lot Number: 0020335905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1