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

Model Number	M00534590
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the catheter did not have a radiopaque marker, however, the procedure was successfully completed with this device.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 fine.
Additional Manufacturer Narrative
Block h6: device code 2306 captures the reportable event of ro marker band missing.Block h10: the returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the device did not present any damage or abnormalities along the device.The radiopaque ring was observed in the tip of the push catheter and it did not present any visual damage or abnormalities.The stent and suture were not returned for analysis.No other issues with the device were noted.The reported event was not confirmed since the returned device showed no evidence of either the alleged issue or any defect which could have contributed to this event.Therefore, 'no problem detected' is selected as the most probable root cause for the complaint.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 biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6), 2020.According to the complainant, during the procedure, it was noticed that the catheter did not have a radiopaque marker, however, the procedure was successfully completed with this device.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 fine.

• 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: 9818747
• Report Number: 3005099803-2020-00850
• Device Sequence Number: 16531910
• Product Code: FGE
• UDI-Device Identifier: 08714729787143
• UDI-Public: 08714729787143
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 11/21/2021
• Device Model Number: M00534590
• Device Catalogue Number: 3459
• Device Lot Number: 0024814653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1