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

Model Number	M00539200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary delivery system was analyzed, and a visual evaluation noted that the guide catheter was partially retracted, the proximal section was broken, stretched also it was bent in several locations, likely due to this condition the stent failed to deploy.The suture hole was torn.The push catheter was kinked approximately at 2cm from distal end, proximal section of the push catheter was cut, cut ends were inspected under magnification and evidence of pressure applied to both sides of the material was observed, it is likely that a sharp tool was used to cut the device.No other issues with the device were noted.The stent was returned loaded on the delivery system, no visual issues were identified with the suture and the stent did not have any visual issue the reported event was not confirmed.As per complaint information the issue occurred during procedure.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink/bend the catheters, this condition can result in issues deploying the stent due to friction between the components at kinked areas in the catheters, kinks/bends on catheters can result in difficulty to retract the guide catheter and consequently issues to release the stent, continued attempts to retract it can result in guide catheter stretching and breakage, also force applied can tear the suture hole.Probably the customer cut the device to try to deploy the stent after the delivery system got damaged.Therefore, "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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, performed on (b)(6) 2019.According to the complainant, during the procedure, inside the patient, when the physician attempted to deploy the stent, it was noticed that the suture did not release and the stent failed to deploy.Another flexima biliary stent was opened and was used to successfully complete the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; guide catheter break.

• 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: 9831489
• Report Number: 3005099803-2020-00869
• Device Sequence Number: 11484628
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: 08714729337362
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 05/14/2021
• Device Model Number: M00539200
• Device Catalogue Number: 3920
• Device Lot Number: 0022122505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1