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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was broken, kinked and stretched.Also, the push catheter was bent at the proximal section.The device was inspected under microscope, it was observed that the push catheter suture hole was torn causing the stent not to deploy.No other issues with the device were noted.The reported event of failed to deploy was confirmed.Upon analysis, the guide catheter was broken, kinked and stretched.Also, the push catheter was bent at the proximal section; also,the catheter push suture hole was torn and the stent may become unable to deploy.Based on complaint information after stent was placed to the specified location, the stent could not be deployed successfully.Due to this information, the push catheter could be bent during manipulation of the device by the technique used during advancing into the scope and the patient anatomy causing resistance to the push suture hole during stent deployment, and as a result to guide catheter beaking, kinking and stretching.The investigation concluded that the most probable cause for this is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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 a flexima biliary stent was used during a endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2021.During the procedure, inside the patient, when the stent was placed, they could not deploy it successfully.The procedure was successfully completed with another flexima 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 reported to be stable.Investigation results revealed that the guide catheter was detached/separated; therefore, this event has been deemed an mdr reportable event.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11697449
• Report Number: 3005099803-2021-01668
• Device Sequence Number: 11636626
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• 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): 04/20/2021

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: 12/01/2022
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0024854237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 56