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

Model Number	M00539220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that implantation of a flexima biliary stent was needed due to the tumor.They followed the instructions and were able to position the flexima biliary stent in the channel; however when a release was performed, they could not release it successfully.It was found that the flexima biliary stent became broken due to how much effort had been exerted.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.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2022.During the procedure, it was noted that implantation of a flexima biliary stent was needed due to the tumor.They followed the instructions and were able to position the flexima biliary stent in the channel; however, when a release was performed, they could not release it successfully.It was found that the flexima biliary stent became broken due to how much effort had been exerted.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.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of stent broken.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was broken and stretched, the broken section was not returned for analysis.The guidewire was stuck in the delivery system and push catheter buckled on the proximal section.The suture was detached and was not returned for analysis.The push catheter was bent on distal section.The stent was still loaded in the delivery system but without the suture, however the suture hole was torn.No other problems with the device were noted.The reported event of stent break was not 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 observed that the proximal section of the guide catheter became broken and stretched, the broken section did not return for analysis, guidewire stuck in the delivery system and push catheter buckled on the proximal section, suture detached and was not returned for analysis, the push catheter was bent on distal section, and the stent was still loaded in the delivery system but without the suture.According to the complaint information, the physician could not proceed with the deployment of the stent inside the patient, after the flexima became broken due to how much effort had been exerted on the device.It is possible that anatomical or procedural factors encountered during procedure could lead to the reported issues.Additionally, the stent returned in good condition and loaded in the delivery system but without the suture.Based on the visual inspection the reported issue of stent break will be documented as no problem detected the device complaint or problem cannot be confirmed.Therefore, based on the information available and the analysis performed, it was determined overall that the investigation conclusion code for the encountered issues will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

• 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: 13585310
• Report Number: 3005099803-2022-00663
• Device Sequence Number: 17553816
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 08/30/2024
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0027941542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG