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

Model Number	M00539210
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of guide catheter detached/separated.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was returned deployed from the delivery system with the guide catheter kinked and separated into two parts, and the push catheter suture hole torn.Based on the media inspection, the photo shows that the stent was still attached to the delivery system, the guide catheter was kinked, and the push catheter suture hole was torn.A microscopic inspection was performed and found that the guide catheter was kinked and separated, and the push catheter suture hole was torn.No other problems with the device were noted.The reported event of stent failure to deploy was confirmed.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failure were caused by manipulation of the device during the procedure.A tortuous anatomy and the technique used by the physician could have caused the reported failure as the pull wire was fully retracted, suture hole torn, and the guide catheter kinked confirming that a device deployment was made.Therefore, the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones in the biliary duct performed on (b)(6) 2023.During the procedure, when the sheath and guidewire were removed to deploy the stent, it did not deploy properly.The duodenoscope was removed and the procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: 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: 17130741
• Report Number: 3005099803-2023-02850
• Device Sequence Number: 12620956
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2025
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0029214881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown