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

Model Number	M00532210
Medical Device Problem Codes	Premature Activation (1484); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was observed with some damages and kinks, the damages were observed under a microscope inspection.No other problems with the device were noted.The reported event was not confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.Upon analysis, it was determined that the stent returned with some damages and it was kinked at one part.A microscope inspection was performed to inspect these issues under magnification.The observed damages and the kink on the stent wouldn't allow a premature deployment of the stent, instead it could have contributed with some difficulties to the deployment of it.Review and analysis of all available information indicated that the root cause of the problems found is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct procedure performed on (b)(6) 2021.During the procedure, it was reported that the stent deployed prematurely.The procedure was successfully completed with another advanix biliary stent.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.Investigation results revealed that the stent was damaged, therefore this event has been deemed an mdr reportable 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: 12531949
• Report Number: 3005099803-2021-04971
• Device Sequence Number: 13786901
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: 08714729786993
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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: 05/14/2022
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 0025514821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 70