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

Model Number	M00537170
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported that a 5 fr advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2020.Reportedly, the patient had a pancreatic fistula and the anatomy was very challenging due to the pancreatic ductal anatomy, making the procedure difficult and complex.According to the complainant, during the procedure, the 5 fr advanix pancreatic stent failed to deploy.The 5 fr stent was removed from the duct and a 4 fr advanix pancreatic stent was inserted.During the placement of the 4 fr pancreatic stent, fluoroscopy revealed a small piece of material which was assumed to be a magnetic resonance marker from the 5 fr stent.The piece seen on fluoroscopy was the size of a marker, but was unable to be retrieved.An angle-tip guidewire was used to successfully deploy the 4 fr advanix pancreatic stent to complete the procedure.There were no patient complications reported as a result of this event.The physician examined the 5 fr advanix stent and no part appeared to be missing.

• 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: 10501211
• Report Number: 3005099803-2020-03672
• Device Sequence Number: 2680080
• Product Code: FGE
• UDI-Device Identifier: 08714729856641
• UDI-Public: 08714729856641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: M00537170
• Device Catalogue Number: 3717
• Device Lot Number: 0024122181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 58