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 the guide catheter was stretched, kinked and detached, also it presented one guidewire inside of it.The distal section of the device was cut, the stent remained attached to the push catheter by the suture thread.The suture hole of the push catheter was torn.The push catheter was kinked and it was observed that the cut presented on the device had evidence that a mechanical tool was used to perform the cut.During functional inspection the guidewire could be removed without issues.A photo was attached in the complaint record showing that the stent was inside the patient however it was not possible to determine any possible failure.The reported event was confirmed.According to product analysis, it is most likely that user manipulation and/or some technique performed while preparing the device may have caused the kinks on the push catheter, once the push catheter was kinked the user may have experienced difficulties to pull out the guide catheter, during this action the guide catheter may have gotten kinked and stretched, finally it is possible that the user applied an extra force which lead the detachment of it and the tear of the suture hole, as consequence of this condition the user was unable to deploy the stent, therefore during the removal of the device from the endoscope it may have performed some technique in order to separate the device which implicated to cut the device as observed.The observed issue of device cut will be documented as a not reported allegation under the code of customer altered product.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Device history records review: 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 procedure in the common bile duct, performed on (b)(6) 2021.During the procedure, when the physician attempted to deploy the stent, the suture was stuck preventing the stent to be deployed.Another flexima biliary stent was attempted to use but the same problem was noticed.A third flexima biliary stent was opened and successfully completed 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: 13203181
• Report Number: 3005099803-2021-07922
• Device Sequence Number: 5934502
• 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: 12/13/2021
• 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