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

Model Number M00539280

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.

Event Description

It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the biliary tract, for biliary dilation on (b)(6) 2023.During the procedure, inside the patient, it was noticed that the guide catheter detached before the physician was able to retract the pull wire to deploy the stent.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.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the flexima biliary stent was returned, and an evaluation noted that there was no visible problem.The delivery system was not returned for evaluation.Therefore, the reported event of guide catheter break was not confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A technical analysis of the guide catheter could not be performed because the delivery system was not returned.Therefore, the most probable cause is cause not established.

Event Description

It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the biliary tract, for biliary dilation on (b)(6) 2023.During the procedure, inside the patient, it was noticed that the guide catheter detached before the physician was able to retract the pull wire to deploy the stent.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.No further information has been obtained despite good faith efforts.

• Brand Name: FLEXIMA BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16934720
• MDR Text Key: 315298371
• Report Number: 3005099803-2023-02485
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 0025705540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 49 KG