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

Model Number	32337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: it was not provided, used the first date of the month of the aware date.
Event or Problem Description
It was reported that the device was missing a radiopaque (ro) marker on the drain.A 10.3 flexima regular w/ro vtcb was selected for use for a biliary procedure.It was noted that there was ro marker on drain.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event: it was not provided, used the first date of the month of the aware date.Device evaluated by manufacturer: the device was returned for analysis.Visual examination revealed that the radiopaque (ro) marker was not present on the device.
Event or Problem Description
It was reported that the device was missing a radiopaque (ro) marker on the drain.A 10.3 flexima regular w/ro vtcb was selected for use for a biliary procedure.It was noted that there was ro marker on drain.There were no patient complications reported.

• Brand Name: FLEXIMA
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9129349
• Report Number: 2134265-2019-11720
• Device Sequence Number: 1749575
• Product Code: FGE
• UDI-Device Identifier: 08714729454960
• UDI-Public: 08714729454960
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023870
• 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,Followup
• Report Date (Section B): 01/02/2020

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: 09/13/2021
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0022656751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1