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	02/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire was broken.A 8.3 flexima catheter was selected for use.During preparation, it was directly noted that upon opening of the device, the tip of the catheter wire was partially separated.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The biliary catheter was returned.No defects were noted and it looks in good condition.The suture string was received cut and residues were noted along the catheter.
Event or Problem Description
It was reported that the wire was broken.A 8.3 flexima catheter was selected for use.During preparation, it was directly noted that upon opening of the device, the tip of the catheter wire was partially separated.The procedure was completed with another of the same device.No patient complications were 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: 9699456
• Report Number: 2134265-2020-01330
• Device Sequence Number: 2857843
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/30/2020

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: 0022656677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1