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

Model Number	M00545660
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; however the device was received with the original pouch showing lot 27707252.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.This event was reported by the distributor.The health care facility is: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a procedure, performed on an unknown date.During the procedure, it was noticed that the guide catheter was separated when the physician attempted to deploy the stent.Another flexima rx biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a procedure, performed on an unknown date.During the procedure, it was noticed that the guide catheter was separated when the physician attempted to deploy the stent.Another flexima rx biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; however the device was received with the original pouch showing lot 27707252.Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached, the detached part was not returned.It was observed that the push catheter presented some kinks.The device was returned with one non-bsc guidewire.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it is possible that user manipulation, some technique performed during procedure and/or even anatomical factors contributed on the device damages causing the kinks along the push catheter and possibly submitting tension on the delivery system, while those conditions were present the user may have experienced difficulties during the retraction/extension of the guide catheter and this may have taken the user to apply a different technique that ended detaching the guide catheter.Therefore, adverse event related to procedure was selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block e1: this event was reported by the distributor.The health care facility is: (b)(6) hospital.

• Brand Name: RX 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: 13581300
• Report Number: 3005099803-2022-00736
• Device Sequence Number: 5680732
• Product Code: FGE
• UDI-Device Identifier: 08714729301837
• UDI-Public: 08714729301837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 07/20/2024
• Device Model Number: M00545660
• Device Catalogue Number: 4566
• Device Lot Number: 0027707252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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 Sex: Unknown