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

Model Number	M00539220
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536); Material Deformation (2976); Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 medwatch will be filed.
Event or Problem Description
Note: this report is three of three complaints that pertain to the same event (mfr report # 3005099803-2021-01662, mfr.Report # 3005099803-2021-01667).It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography in the biliary duct performed on (b)(6) 2021.During the procedure, three stents were deployed unsuccessfully.It was reported that they had difficulty retracting the pull wire to release the suture, and the suture was tangled.A photo of the device was provided and showed that the guide catheter kinked.The procedure was cancelled due to this event and rescheduled.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report is three of three complaints that pertain to the same event (mfr report # 3005099803-2021-01662, mfr.# 3005099803-2021-01664 and mfr.Report # 3005099803-2021-01667).It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography in the biliary duct performed on (b)(6) , 2021.During the procedure, three stents were deployed unsuccessfully.It was reported that they had difficulty releasing the suture, and the suture was tangled.A photo of the device was provided and showed that the guide catheter kinked.The procedure was cancelled due to this event and rescheduled.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter state: 11 initial reporter phone: extension number 3010 block h6: device code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was returned loaded in the delivery system indicating that it could not be deployed.The guide catheter was kinked/bent in several locations; also it was buckled, stretched and broken at the proximal section.The push catheter was kinked/bent in several locations.The suture was twisted and the suture hole was torn.Additionally, the stent was bent in some locations, and the guide catheter was kinked/bent and buckled at the proximal section.No other problems 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 integrity.Handling and manipulation of the device or during its use can lead to kink/bend the catheters and stent, user technique when the device is removed from its package or advancing the device through the scope can kink the catheters and stent.This condition can cause friction between the components at kinked/bent areas in the catheters and stent and continued attempts to release the stent or force retracting the guide catheter in order to release the stent can result in guide catheter stretching and breaking.Additionally, the suture hole torn indicates that the suture was submitted to tension forces resulting in tearing the suture hole.Rotation of the delivery system during placement can twist the suture around the delivery system.Review and analysis of all available information indicated that the root cause of the problems found 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.Block h11: correction to block block b5 (describe event or problem) block h6: removed device code a0510 for pullwire retraction problem.

• 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: 11686941
• Report Number: 3005099803-2021-01664
• Device Sequence Number: 11545375
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 08/14/2023
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0025861907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1