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

Model Number	M00534300
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The advanix biliary was not returned, however the customer provided five photos and a visual evaluation noted that one guidewire peeled and two photos showed at the tip of the guidewire part of the guide catheter detached.Also, it stuck within the guidewire and severely stretched.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, the media analysis performed, it was determined that the photos showed one guidewire peeled and two photos showed the part of the guide catheter detached, stuck within the guidewire and severely stretched.The device wasn't returned for analysis and a deep inspection on the delivery system and all the involved components couldn't be performed to determine the most possible root cause of the observed problems.Review and analysis of all available information indicated that the root cause of the problems found is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
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 biliary system performed on (b)(6) 2021.During the procedure, it was reported that when they tried to deploy the stent, the hydrophilic end of the jagwire got caught in the guide catheter and became bunched up, and had to pull everything out from the patient.Therefore, the stent failed to deploy.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was broken.

• 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: 12626757
• Report Number: 3005099803-2021-05293
• Device Sequence Number: 1428005
• Product Code: FGE
• UDI-Device Identifier: 08714729787396
• UDI-Public: 08714729787396
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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 Model Number: M00534300
• Device Catalogue Number: 3430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1