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

Model Number	M00534220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event initial reporter phone: (b)(6).(b)(4).The returned advanix-naviflex rx biliary preloaded stent was analyzed.It was observed that the pull wire, the guide catheter and the push catheter were severely bent/kink and the push catheter suture hole was torn.The stent returned loaded in the delivery system.The pull wire was pulled out beyond its returned point.The pull wire and guide catheter was detached from the cannula joint point due to the condition of the device the functional test was not performed.No other issues with the device were noted.The reported event was not confirmed.Based on the provided and collected information, it is most likely that procedural and anatomical factors encountered during the procedure could have affected the overall performance of the device and its integrity.The kinks in the pull wire and push catheter could be caused when they tried to insert the unit into the scope.Additionally many attempts in order to release the stent impacted the guide catheter, this lead to a kink and due to this, it got detached from the pull wire and the cannula joint point, also the push catheter suture hole was torn, all these damages affecting the overall performance of the device.The investigation concluded that adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.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 used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the biliary.The exact date of the procedure was not reported.According to the complainant, during the procedure, when the physician attempted to deploy the stent, the guidewire was stuck and the stent failed to deploy.The device was replaced and the procedure was completed with another advanix biliary stent.No patient complications were reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of guide catheter detached/separated.

• 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: 11298592
• Report Number: 3005099803-2021-00406
• Device Sequence Number: 17392744
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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 Expiration Date: 10/05/2022
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 0026134229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1