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

Model Number M00523440

Device Problems Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted during a procedure performed on december 8, 2023.During the procedure, the guide catheter broke, the suture separated, and the stent could not be deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.

Manufacturer Narrative

Blocks d4 (lot number, expiration date) and h4 (device manufacture date) have been updated with the additional information received on january 4, 2024.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, the guide catheter broke, the suture separated, and the stent could not be deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Blocks d4 (lot number, expiration date) and h4 (device manufacture date) have been updated with the additional information received on march 7, 2024.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Block h10: the flexima plus biliary stent and delivery system were returned for analysis.Visual analysis found that the deployment suture was attached to the device, and the guide catheter was slightly bent.Visual and microscopic inspection found that the push catheter suture hole was torn.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported events of guide catheter break and suture detachment because the guide catheter of the returned device was slightly bent, and the suture was still attached to the push catheter.Moreover, the reported event of stent failure to deploy was confirmed, and the investigation concluded that this event and the additional investigation findings of push catheter suture hole torn, and guide catheter bent were most likely due to procedural factors such as lesion characteristics, handling of the device and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, the guide catheter broke, the suture separated, and the stent could not be deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, the guide catheter broke, the suture separated, and the stent could not be deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Block h10: the flexima plus biliary stent and delivery system were returned for analysis.Visual analysis found that the deployment suture was attached to the device, and the guide catheter was slightly bent.Visual and microscopic inspection found that the push catheter suture hole was torn.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported events of guide catheter break and suture detachment because the guide catheter of the returned device was slightly bent, and the suture was still attached to the push catheter.Moreover, the reported event of stent failure to deploy was confirmed, and the investigation concluded that this event and the additional investigation findings of push catheter suture hole torn, and guide catheter bent were most likely due to procedural factors such as lesion characteristics, handling of the device and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• Brand Name: FLEXIMA PLUS 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: 18438411
• MDR Text Key: 331924434
• Report Number: 3005099803-2023-06966
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2024

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 Model Number: M00523440
• Device Catalogue Number: 2344
• Device Lot Number: 0032284895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/04/2024; 02/02/2024; 03/07/2024
• Supplement Dates FDA Received: 02/01/2024; 02/28/2024; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• 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