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

Model Number	M00536560
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 pancreatic stent was used during a pancreatic duct stent placement procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the stent was found to be kinked and twisted leading the stent to be unable to release.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: device code a0406 captures the reportable event of pancreatic stent kinked and deformed.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that it was out of its pouch and it was slightly bent.Additionally, the proximal end of the stent was deformed and these damages could have caused issues to deploy the stent.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is most likely that procedural or anatomical factors encountered during procedure could have damaged the stent.Interaction with the scope and guidewire could have contributed with the observed damages.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 pancreatic stent was used during a pancreatic duct stent placement procedure performed on (b)(6), 2021.According to the complainant, during the procedure, the stent was found to be kinked and twisted leading the stent to be unable to release.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.It happened during the procedure and it was noticed that the stent was twisted when the device was unpacked.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11274363
• Report Number: 3005099803-2021-00273
• Device Sequence Number: 4228769
• Product Code: FGE
• UDI-Device Identifier: 08714729857501
• UDI-Public: 08714729857501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 08/31/2021
• Device Model Number: M00536560
• Device Catalogue Number: 3656
• Device Lot Number: 0025305406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1