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

Model Number	M00537230
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that the advanix pancreatic stent was used in an endoscopic retrograde cholangiopancreatography for stent placement procedure.The advanix pancreatic stent kinked at the pigtail despite its placement with the appropriate naviflex pusher.The kinked pancreatic stent was successfully implanted into the patient.There were no patient issues.
Additional Manufacturer Narrative
Block b3: date of event was approximated to march 01, 2021 based on the date the manufacturer became aware of the event.Block h6: medical device problem code a0406 captures the reportable event of pancreatic stent kinked.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.Block h11: correction to h6: updated medical device problem code a2201 device difficult to setup or prepare.Correction to d6a: updated implant date (b)(6) 2021.
Event or Problem Description
It was reported to boston scientific corporation that the advanix pancreatic stent was used in an endoscopic retrograde cholangiopancreatography for stent placement procedure.The advanix pancreatic stent kinked at the pigtail despite its placement with the appropriate naviflex pusher.The kinked pancreatic stent was succesfully implanted into the patient.There were no patient issues.

• 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: 11624888
• Report Number: 3005099803-2021-01283
• Device Sequence Number: 3291118
• Product Code: FGE
• UDI-Device Identifier: 08714729856825
• UDI-Public: 08714729856825
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/07/2021

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: 03/29/2022
• Device Model Number: M00537230
• Device Catalogue Number: 3723
• Device Lot Number: 0026107276
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1