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

Model Number	M00532180
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(b)(4).The returned advanix naviflex biliary stent was analyzed, and a visual evaluation noted that the pig tails and the holes were kinked.No other issues with the device were noted.The reported event was not confirmed.However, the stent pigtail section and holes were kinked.It is likely related to manipulation before the procedure when they tried to load the stent onto the delivery system.Some additional force applied could lead to the kinks.This affects the set up of the device.Also, it was mentioned in the device instructions for use (ifu) that the advanix biliary stent was used with naviflex rx delivery system, and it is unknown which delivery system was used during the set up of this stent.This also could contribute to the reported event.Therefore, the most probable root cause for this event is adverse event related to procedure.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 naviflex biliary stent was being used during endoscopic retrograde cholangiopancreatography (ercp) procedure in the duodenal papilla performed on (b)(6) 2020.According to the complainant, during introduction, outside the patient, the stent could not cross the advancer.The procedure was successfully 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.Investigation results revealed that the stent was damaged therefore this event has been deemed an mdr reportable event.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10748883
• Report Number: 3005099803-2020-04925
• Device Sequence Number: 14218116
• Product Code: FGE
• UDI-Device Identifier: 08714729786979
• UDI-Public: 08714729786979
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 09/03/2021
• Device Model Number: M00532180
• Device Catalogue Number: 3218
• Device Lot Number: 0024376582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65