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

Model Number	M00534690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
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 an advanix rx biliary stent was removed during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct on (b)(6) 2018.The stent was reportedly placed a few weeks before the planned removal procedure, however, the exact implant date was not reported.According to the complainant, during a planned stent removal, when the physician attempted to remove the stent using a snare, the stent broke in half.There was no extra device used for the retrieval.The stent was successfully removed and the procedure was completed.There were no serious injury or adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the returned device was performed and found that the stent broken at its distal end; consequently, confirming the reported complaint.Based on the product analysis, it is most likely that the device could have been excessively manipulated, since the failure found (stent broken) is an issue that could have been generated while the device is being handled by the user and/or excess of force applied to the product which might have impacted its integrity and functionality causing problems during the stent removal.Therefore, 'cause traced to component failure' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and no anomalies were observed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was removed during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct on (b)(6) 2018.The stent was reportedly placed a few weeks before the planned removal procedure, however, the exact implant date was not reported.According to the complainant, during a planned stent removal, when the physician attempted to remove the stent using a snare, the stent broke in half.There was no extra device used for the retrieval.The stent was successfully removed and the procedure was completed.There were no serious injury or adverse patient effects reported as a result of this event.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7895568
• Report Number: 3005099803-2018-60517
• Device Sequence Number: 119035
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 07/08/2020
• Device Model Number: M00534690
• Device Catalogue Number: 49845
• Device Lot Number: 0022348195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1