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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code: (b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the gallbladder performed on (b)(6) 2022.During the procedure, when they attempted to deploy the stent, the inner guide catheter was fractured.It was reported that the broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece the procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the gallbladder performed on february 21, 2022.During the procedure, when they attempted to deploy the stent, the inner guide catheter was fractured.It was reported that the broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece the procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Medical device code a0401 captures the reportable event of guide catheter broken.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached, stretched and kinked.Additionally, the push catheter was kinked.The push catheter suture hole was torn.No other problem with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; after analysis it was determined that the guide catheter was stretched, kinked and detached, the suture hole of the push catheter was torn and the push catheter presented several kinks.It's possible that the kinks presented on the push catheter may be related to user manipulation during the procedure and or even during the preparation of the device, once the push catheter presented those kinks the guide catheter may have experimented difficulties to be pulled out, this may have taken the user to apply some technique and/or some extra force that ended stretching and kinking the guide catheter, as consequence of these conditions the it ended detaching the guide catheter, also as consequence of the tough movement the suture hole got torn.Therefore, based on the analysis performed and all the information gathered from the customer and the issues found, the overall investigation conclusion code assigned will be "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.

• 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: 13857376
• Report Number: 3005099803-2022-01224
• Device Sequence Number: 1257975
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2022

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: 09/21/2024
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0028066802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 66 KG