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	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 boston scientific corporation that a flexima rx biliary stent was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6) 2021.During the procedure, after the stent was positioned in the target site, the guide catheter became separated and fell into the duodenum.The broken guide catheter was successfully removed using a pair of forceps.The procedure was successfully completed with another flexima rx 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 as "no patient injury".A photo of the complaint device was provided and showed that the guide catheter broken.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the stent was not returned.The push catheter had several kinks.The guide catheter was detached and kinked.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis, it was determined that the push catheter was several kinked, the guide catheter returned detached and kinked, the stent didn't return for analysis.The guide catheter detached and kinked may be related to an extra force applied while extending/retracting the pull wire that ended detaching the guide catheter and kinking it.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
It was reported boston scientific corporation that a flexima rx biliary stent was used during a endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6), 2021.During the procedure, after the stent was positioned in the target site, the guide catheter became separated and fell into the duodenum.The broken guide catheter was successfully removed using a pair of forceps.The procedure was successfully completed with another flexima rx 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 as "no patient injury".A photo of the complaint device was provided and showed that the guide catheter broken.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11941079
• Report Number: 3005099803-2021-02494
• Device Sequence Number: 4176067
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 02/02/2024
• Device Model Number: M00545660
• Device Catalogue Number: 4566
• Device Lot Number: 0026739835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1