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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).A visual evaluation of the returned device found that the guide catheter was broken and became stretched at its proximal section.The touhy borst was not returned for analysis.Based on the product analysis, this damage of the guide catheter could have caused the detachment of the touhy borst.It is possible that the way in which the device was handled and manipulated may have contributed to the failure encountered (guide catheter stretched and broken).Once the guide catheter have been damaged it would become difficult/unable to be retracted; excessive force used can also cause the detachment of the touhy borst which is consistent with the analysis of the returned product performed since the section of the guide catheter found as damaged is the one where the touhy borst goes placed; this type of failures at the same time can cause difficulties during deployment of the stent in a clinical setting.Therefore, 'cause traced to component failure' is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreotography (ercp) procedure performed in the common bile duct on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to deploy the stent, the touhy boorst was unable to loosen.Therefore, the stent was failed to be deployed.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed the guide catheter broke, 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: 8011393
• Report Number: 3005099803-2018-61067
• Device Sequence Number: 16525350
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/26/2018

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: 05/08/2021
• Device Model Number: M00539210
• Device Catalogue Number: 49535
• Device Lot Number: 0022094070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR