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

Model Number	M00539280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure for bile drainage in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, it was noticed that the guide catheter broke.The broken piece of guide catheter was removed by a pair of forceps and another flexima biliary stent was opened and successfully completed the procedure.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
Initial reporter facility name: (b)(6).(b)(4).
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) 00affiliated to the medical school of shanghai jiaotong university.Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was returned deployed.The device was inspected carefully and found no issues.The stent, suture thread and the suture hole were returned in good conditions.The guide catheter was returned attached to the push catheter and did not present any issues.The guide catheter was not broken.The functional test cannot be performed due to the device was returned actioned.No problem with the device were noted.The reported event was not confirmed.According to the analysis, since the device exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality, shelf life/expiration day exceeded is selected as the conclusion code of the reported problem.After analysis of the device returned it was determined that the device was returned in good conditions.The guide catheter was returned attached to the push catheter in good conditions, and the guide catheter did not break.The functional test cannot be performed due the device was returned actioned, the unit returned did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, no problem detected is selected as the most probable root cause for the complaint.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure for bile drainage in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, it was noticed that the guide catheter broke.The broken piece of guide catheter was removed by a pair of forceps and another flexima biliary stent was opened and successfully completed the procedure.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.

• 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: 15509890
• Report Number: 3005099803-2022-05308
• Device Sequence Number: 4971771
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• 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): 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 0024286280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 53 KG