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 Patient Involvement (2645)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke.Upon preparation outside the patient's body, the suture of a 10.3 flexima drainage catheter broke.The procedure was completed with another device of the same size.No complications reported and patient did well.

• 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: 9145763
• Report Number: 2134265-2019-11782
• Device Sequence Number: 2622200
• Product Code: FGE
• UDI-Device Identifier: 08714729454960
• UDI-Public: 08714729454960
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 01/10/2022
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0023174199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1