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

Model Number	M00534640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 preload stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was noticed that the guide catheter broke.The device was removed and the procedure was successfully completed with another stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
F10: problem code 1069 captures the reportable event of  guide catheter broke.  h10: a visual evaluation of the returned device was performed and found that the guide catheter was not separated from the delivery system; consequently, not confirming the reported complaint.The initial report of guide catheter broken was not confirmed, however, based on the product analysis, a visual assessment identified that the push catheter torn from the handle until the guidewire exit port, the push catheter and pull wire were kinked in several locations and the guide catheter was bent in several locations.As per complaint information the issue occurred during procedure.It is most likely that procedural or anatomical factors were encountered during the procedure which may have limited the overall performance of the device.Device under tortuous condition due to patient anatomy or customer use / manipulation / maneuvering can kink/bend the catheters and pull wire.Once the catheters/pull wire are kinked/bent, this would cause excessive friction between the components at kinked areas, this condition can result in difficulty to retract the guide catheter/pull wire, consequently causing issues to deploy the stent.Continued attempts to retract the guide catheter/pull wire or excessive force applied to the device in order to release the stent can result in tearing the push catheter.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications and no anomalies were observed.H11: correction to b5: event date changed to (b)(6) 2018.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preload stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was noticed that the guide catheter broke.The device was removed and the procedure was successfully completed with another stent.There were no patient complications 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: 8091074
• Report Number: 3005099803-2018-61452
• Device Sequence Number: 19164222
• Product Code: FGE
• UDI-Device Identifier: 08714729787198
• UDI-Public: 08714729787198
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101314
• 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,Followup
• Report Date (Section B): 01/11/2019

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: 06/12/2020
• Device Model Number: M00534640
• Device Catalogue Number: 3464
• Device Lot Number: 0022244030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1