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

Model Number	M00532190
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported lot number could not be matched to the reported device upn.Therefore, the lot expiration and device manufacture dates are unknown at this time. however, the complainant stated that the device was used prior to the expiration date.(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¿ biliary stent was removed from a patient during an endoscopic retrograde biliary drainage (erbd) procedure in the common bile duct performed on (b)(6) 2018.On (b)(6) 2018 the advanix¿ biliary stent was implanted in the common bile duct.According to the complainant, it was noticed that the stent was kinked during deployment.After 7 days, the bilirubin level elevated and the stent was blocked.The device was removed on (b)(6) 2018 and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the stent has some blackened areas, also it is kinked in several locations.Based on the product analysis, most likely some anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.Handling and manipulation of the device during stent placement can result in stent kinking, customer use/manipulation/maneuvering, patient stricture, could have been factors that contributed with the damages observed on the stent, there are manufacturing processes and inspections to ensure that finished devices meet specifications.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.Labeling review was performed and found that dfu instructions were not followed, the device may have caused or contributed to the reported event and the risk of the reported event noted within the labeling.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ biliary stent was removed from a patient during an endoscopic retrograde biliary drainage (erbd) procedure in the common bile duct performed on (b)(6) 2018.On (b)(6) 2018 the advanix¿ biliary stent was implanted in the common bile duct.According to the complainant, it was noticed that the stent was kinked during deployment.After 7 days, the bilirubin level elevated and the stent was blocked.The device was removed on (b)(6) 2018 and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ADVANIX¿ BILIARY
• 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: 7533229
• Report Number: 3005099803-2018-01572
• Device Sequence Number: 16181084
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101786
• 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,Followup
• Report Date (Section B): 04/26/2018

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: M00532190
• Device Catalogue Number: 3219
• Device Lot Number: 71770074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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
• Patient Age: 54 YR