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

Model Number	M00534690
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
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).A visual evaluation of the returned device was performed and found that the pull wire cap was detached from the pull wire, proximal tip of pull wire is bent indicating it was properly placed during manufacturing process.The push catheter is kinked in several locations.The pull wire is completely retracted until point of no return, but the stent was still attached to the delivery system which indicates that it failed to deploy the stent during procedure.The guide catheter was manually removed from the delivery system, it was detached/separated from the delivery system.Once the guide catheter was removed, it was observed that it was kinked in several locations.The stent does not present any visual issue.Based on the product analysis, the event occurred during the procedure.Probably procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, cause traced to component failure is selected as the most probable root cause for the complaint.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during an endoscopic sphincterotomy procedure in the common bile duct, performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent in the common bile duct, it did not deploy.The procedure was successfully completed using a different device of a different model.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.This event has been deemed a reportable event based on the investigation results; guide catheter broke.

• 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: 7969827
• Report Number: 3005099803-2018-60872
• Device Sequence Number: 1214353
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 10/16/2018

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: 01/16/2020
• Device Model Number: M00534690
• Device Catalogue Number: 49845
• Device Lot Number: 0021618498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR