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

Model Number	M00539200
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).(b)(4).The returned flexima biliary was analyzed, and a visual evaluation noted that microscopic inspection of the suture hole of the push catheter was torn.It was observed that the guide catheter was kinked and it was detached, the push catheter presented some kinks as well.The guide catheter had one guidewire inside of it, during functional inspection it could be removed without issues.The stent and suture was not returned.The reported event was confirmed.According to product analysis, the push catheter kinked may be related to user manipulation during the preparation of the device, some technique applied during the procedure and/or even tortuous anatomy could have contributed on this issue, once the push catheter was kinked the user experienced difficulties to release the stent and this may have taken the user to apply a different technique and/or apply an extra force, as consequence the guide catheter got kinked and finally detached, also during the attempts of deployment the suture hole got torn due these conditions.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
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 in the common bile duct on (b)(6) 2021 for the treatment of secondary sclerotic cholangitis.During the procedure and inside the patient, the flexima stent failed to deploy.The guidewire was completely removed for deployment, but the suture did not peel away, preventing stent deployment.A second flexima biliary stent was attempted to be used, but the same issue occurred.A third flexima biliary stent device was successfully used to complete the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of guide catheter broken.

• 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: 13206293
• Report Number: 3005099803-2021-08160
• Device Sequence Number: 17280398
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: 08714729337362
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/10/2022

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: 12/02/2021
• Device Model Number: M00539200
• Device Catalogue Number: 3920
• Device Lot Number: 0023019865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• 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