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

Model Number	M00539220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the push catheter had several kinks.The proximal section of the guide catheter was detached and was not returned.The stent was attached with the suture to the push catheter.Functional inspection couldn't be performed due the proximal section of the guide catheter was detached.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis, it was determined that the push catheter had several kinks.The proximal section of the guide catheter was detached and was not returned.Functional inspection couldn't be performed due the proximal section of the guide catheter was detached.The push catheter kinked may be related to user manipulation and or some technique applied during procedure, these kinks avoided a smoothly extension or retraction of the guide catheter, after the resistance was present the user could have applied an extra force while trying to pull out the guide catheter, therefore this extra force could have leaded the detachment of the proximal section of the guide catheter, these encountered issues confirmed the reported complaint.Review and analysis of all available information indicated that the root cause of the problems found 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 a endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.During procedure, it was noted that the stent was introduced through the guidewire and was positioned in the site, however it was blocked and was unable to deploy.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was broken therefore this event has been deemed an mdr reportable event.See investigation summary for more details.

• 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: 12245448
• Report Number: 3005099803-2021-03668
• Device Sequence Number: 2871053
• 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
• Report Date (Section B): 07/29/2021

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: 07/13/2023
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0025705544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1