MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ADVANIX¿ PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537510
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Perforation (2001)
Date of Event	05/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(b)(4).The device has not been received for analysis.Upon receipt and 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 kit was implanted in the pancreatic duct of a patient during a pancreatic duct stent placement procedure, performed on (b)(6) 2018.No issues were noted with the device during the placement procedure.On (b)(6) 2018, the patient complained of pain on the right abdomen.On (b)(6) 2018, computed tomography scan was performed and confirmed that the stent had perforated the intestinal wall.The image was examined and the physician found that the pancreatic duct migrated from the pancreatic duct to the large intestine, and it perforated the large intestine wall.Inflammatory findings were also observed from the test results.On (b)(6) 2018, the migrated stent was removed using a snare with colonoscope.Endoscopic clipping procedure was performed.An antibiotic was administered.The patient was then under follow up observation.No additional procedures have been planned for this patient.Per the physician¿s assessment, after the stent migrated from ileocecal valve, it is most likely that perforation occurred because the stent remained in a state perpendicular to the intestinal wall for long time.This patient has many diverticula, which is different from normal.But it is unknown whether the perforation occurred by the number, size and place of diverticula.The physician also felt that the stent was getting hard.

• Brand Name: ADVANIX¿ PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7634533
• Report Number: 3005099803-2018-01964
• Device Sequence Number: 1819057
• Product Code: FGE
• UDI-Device Identifier: 08714729856283
• UDI-Public: 08714729856283
• Combination Product (Y/N): N
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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 Model Number: M00537510
• Device Catalogue Number: 3751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/25/2018
• 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