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	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).A visual evaluation of the returned flexima biliary stent was performed.The stent was returned loaded and no issues were found.However, the guide catheter was found stretched and detached in the proximal section of the device, additionally, it was found bent/kinks in the guide catheter and the push catheter; consequently, confirming the reported complaint.Based on the product analysis, there was a biliary stricture in the common bile duct during procedure, it's important to mention that this anatomical factor can cause resistance and/or friction during the deployment of the stent, the device may become difficult unable to be properly/smoothly advanced/handled and at the same time impacting the functionality of the device generating the observed guide catheter and the push catheter bent\kinks, the continued attempts to retract the guide catheter or force applied to the device in order to release the stent in addition to the found bent/kinks can result in the found guide catheter stretched and detached issues.Therefore the most probable root cause for this event is "adverse event related to patient condition".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.The patient was diagnosed with stones in the bile duct and ercp was performed.According to the complainant, during the procedure, after the contrast was injected, it was found that there was a stricture in common bile duct instead of stones.Sphincterotomy with preloaded truetome jag 44 (lot 24064491) was performed and stent placement was made, however, the stent was not deployed as it is supposed to and the stent was removed from the patient.The procedure was successfully completed 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.

• 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: 9591035
• Report Number: 3005099803-2019-06487
• Device Sequence Number: 13546623
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/15/2020

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: 11/04/2021
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0022888888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR