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

Model Number	M00545670
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was reported that the guide catheter was broken.A photo of the complaint device was provided and showed that the push catheter was kinked.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.
Additional Manufacturer Narrative
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 photo showed the device with the push catheter kinked.The reported complaint of 'guide catheter detached' cannot be confirmed.No other problems with the device were noted.The reported event of guide catheter detached was not confirmed, based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; after media analysis it was determined that the push catheter was kinked.It's most likely that user manipulation during the procedure and/or some technique performed ended kinking the push catheter as observed.Therefore, the investigation concluded that adverse event related to procedure is 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.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that a flexima rx biliary stent was used during an an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was reported that the guide catheter was broken.A photo of the complaint device was provided and showed that the push catheter was kinked.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.

• 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: 13479107
• Report Number: 3005099803-2022-00608
• Device Sequence Number: 5462181
• Product Code: FGE
• UDI-Device Identifier: 08714729301844
• UDI-Public: 08714729301844
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 07/07/2023
• Device Model Number: M00545670
• Device Catalogue Number: 4567
• Device Lot Number: 0025683131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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