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

Model Number	M00534290
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Use of Device Problem (1670); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the stent presented the suture thread and it was kinked, one barb was torn.It was observed the pull wire kinked and the cap was detached.The push catheter had several kinks.Microscope inspection revealed that the suture holes of the stent and push catheter were fully torn.No other issues with the device were noted.The reported event was confirmed.According to product analysis, pull wire kinked and the cap detached may be related to some user manipulation while applying an extra force in order to deploy the stent, this action could be related to the difficulties provided by the kinks on the push catheter avoiding a smoothly deployment of the stent, once the user applied this extra force the device was submitted to some tension and the different conditions trough the procedure contributed to the tears observed in the suture holes.As consequence of these conditions the suture thread remained in the stent and the stent got kinked and tearing one barb.As it was mentioned these conditions evidenced a deployment failure instead of a premature deployment.Therefore, adverse event related to procedure 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.This event was reported by the distributor.The physician is: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) calculus removal procedure in thegall bladder performed on (b)(6) 2021.During preparation, when the physician attempted to deploy the stent, the stent deployed prematurely and fell off by itself.Another advanix biliary stent was opened and successfully completed the procedure.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 barb was torn, 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: 12657926
• Report Number: 3005099803-2021-05372
• Device Sequence Number: 1231522
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: 08714729787389
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 05/09/2021
• Device Model Number: M00534290
• Device Catalogue Number: 3429
• Device Lot Number: 0023774602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77