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

Model Number	M00532190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 going to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct performed on (b)(6) 2020.According to the complainant, during preparation, the device was noted to be fractured.The procedure was completed successfully 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 noted to be stable.
Additional Manufacturer Narrative
Block e1: initial reproter state/province: (b)(6).Block h6: device code 1069 captures the reportable event of stent broken.Block h10: the returned advanix biliary stent was analyzed, and a visual evalaution noted that the stent had no broken or detached areas found during the testing process, however, a kink was found in the pigtails section of the stent.No other issues with the device were noted.The reported event was not confirmed.However, according to the analysis, the stent was observed to have kinked in the pigtail section.This issue occured during the preparation.It is possible that operational factors, such as user technique/handling during preparation contributed to the observed kink in the stent.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.Therefore, adverse event related to procedure is selected as the most probable root cause for this complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was going to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct performed on (b)(6) 2020.According to the complainant, during preparation, the device was noted to be fractured.The procedure was completed successfully 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 noted to be stable.

• 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: 10359261
• Report Number: 3005099803-2020-03071
• Device Sequence Number: 14243670
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• 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,Followup
• Report Date (Section B): 08/28/2020

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: 03/17/2022
• Device Model Number: M00532190
• Device Catalogue Number: 3219
• Device Lot Number: 0025365406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 60