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

Model Number	M00532880
Medical Device Problem Codes	Positioning Failure (1158); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2021.During the procedure, it was noted that the stent would not release from the catheter.It was reported that they attempted to use the elevator, withdrew everything and tried to cannulate but it failed to deploy.The procedure was rescheduled the next day and was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned advanix biliary was analyzed, and a visual evaluation noted that the stent presented one end and one barb damaged.The pull wire was dislocated and kinked.The push catheter was broken and kinked close to the proximal section; also, the push caheter was torn.The suture holes were inspected under microscope and both were found torn.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.During the product analysis, it was found that the stent presented one end and one barb damaged, and microscope inspection revealed that the suture holes were torn.It was found that the pull wire was kinked and dislocated, the push catheter was torn and also broken.Functional inspection couldn't be performed due the dislocation and kinks of the pull wire.The torn suture holes indicate that there were problems through the process of deployment, these tears may have been caused by some resistance experienced while trying to release the stent, this resistance could be related to the kinks on the push catheter possibly caused by user manipulation and/or some technique applied during procedure.Once the resistance was felt and the action of trying to release the stent was performed, this could have ended up dislocating the pull wire and kinking it; as consequence of these, the push catheter got torn and broken at one part, the observed damages on the stent could be related to the same issues through the process of deployment and/or some manipulation applied by the user.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) procedure in the common bile duct performed on (b)(6) 2021.During the procedure, it was noted that the stent would not release from the catheter.It was reported that they attempted to use the elevator, withdrew everything and tried to cannulate but it failed to deploy.The procedure was rescheduled the next day and was successfully completed with another advanix biliary 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: 12196439
• Report Number: 3005099803-2021-03416
• Device Sequence Number: 19730555
• Product Code: FGE
• UDI-Device Identifier: 08714729786795
• UDI-Public: 08714729786795
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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 Model Number: M00532880
• Device Catalogue Number: 3288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1