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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima plus (stent and delivery system) was analyzed, and a visual evaluation noted that the stent was returned loaded to the delivery system and the guide catheter was kinked/broken and stretched.The push catheter was kinked.The suture hole was severely torn.No other issues with the device were noted.The reported event was not confirmed.Based on the product analysis, handling and manipulation of the device during its use can lead to kink/bend of the catheters, user technique when they insert the unit into the scope can kink the catheters, this condition can cause friction between the components at kinked/bent areas in the catheters.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 suture hole torn indicates that the suture was properly placed in the device and it was submitted to tension forces resulting in tearing the suture hole.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 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 biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for a suspected biliary stones in the common bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, the push catheter broke.They had to pull the whole device and the wire out and had to recannulate and tried again with second stent, however the push catheter still broke.A third stent was reopened and tried to push very slowly, also the physician changed the position of the scope and the stent was successfully deployed.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 good.Investigation results revealed that the guide catheter was broken therefore this event has been deemed an mdr reportable event.

• 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: 11004516
• Report Number: 3005099803-2020-06014
• Device Sequence Number: 870082
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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): 12/14/2020

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: 06/17/2023
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0025607969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR