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

Model Number	M00539210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation was performed on the returned device, one portion of the guide catheter was returned unloaded of the sheath and it was found stretched and broken in the medium section, the other portion was returned loaded of the sheath.Additionally, it was found bent/kinks in the guide catheter, also, the push catheter suture hole was observed torn; consequently, confirming the reported complaint.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use in addition of continued attempts to retract the guide catheter or force applied to the device in order to release the stent can lead to the guide catheter stretched and broken issue, also the guide catheter kinks and push catheter suture hole torn, these device condition can result in issues deploying the stent.Therefore the most probable root cause for this event is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to deploy the flexima biliary stent, the guide catheter became twisted and the stent was unable to be released from the guide "caheter".The procedure was successfully "compteted" with another flexima 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 stable.This event has been deemed a reportable event based on the investigation results; guide catheter broken.

• 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: 9516463
• Report Number: 3005099803-2019-06161
• Device Sequence Number: 19606919
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2019

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: 07/24/2021
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0022424584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1