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

Model Number	M00545550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Product analysis: the returned flexima rx delivery system and one stent was analyzed, and a visual evaluation noted that the push catheter and guide catheter were kinked/bent in several locations.The guide catheter was detached from the delivery system.Even though the functional inspection was not performed, findings from visual assessment indicated that likely there were issues to deploy the stent during the procedure.No other issues with the device were noted.The reported event was confirmed.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Patient anatomy and customer maneuvering during the use of the device can lead to kink the catheters.Once the catheters are kinked/bent, this condition can cause resistance at the moment to retract the pull wire/guide catheter which can lead to issues deploying the stent, continued attempts to deploy the stent or force applied retracting the pull wire in order to release the stent can result in guide catheter detachment due to friction between the components (push/guide catheter) at kinked/bent areas.Therefore, the most probable root cause is adverse event related to procedure.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 rx biliary stent was used during a biliary stent placement in the lower bile duct, performed on (b)(6) 2020.According to the complainant, during the procedure, when the stent was released, they have observed that the stent was unable to separate from the delivery system.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was broken therefore this event has been deemed an mdr reportable event.

• 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: 9922648
• Report Number: 3005099803-2020-01431
• Device Sequence Number: 3272483
• Product Code: FGE
• UDI-Device Identifier: 08714729337850
• UDI-Public: 08714729337850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 07/07/2022
• Device Model Number: M00545550
• Device Catalogue Number: 4555
• Device Lot Number: 0024067295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1