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

Model Number	M00539320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 mdr 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 procedure in the bile duct, performed on (b)(6) 2021 it was reported that, when the physician opened the package, the stent was broken.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
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Medical device problem code a0401 captures the reportable event of stent break.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was not broken, it did not have any visual issue/damage.The delivery system was not returned for analysis.No other issues with the device were noted.The reported event was not confirmed.Based on product analysis, and all compiled information, the most probable cause of this event is no problem detected since the complaint included a returned device which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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 bile duct, performed on (b)(6) 2021 it was reported that, when the physician opened the package, the stent was broken.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.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11376374
• Report Number: 3005099803-2021-00677
• Device Sequence Number: 4038123
• Product Code: FGE
• UDI-Device Identifier: 08714729162636
• UDI-Public: 08714729162636
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 11/30/2023
• Device Model Number: M00539320
• Device Catalogue Number: 3932
• Device Lot Number: 0026439819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1