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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION FLEXIMA; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 32337
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: populated as (b)(6) 2019 as there is no known event date.Populated as the first day of the month of the bsc aware date.
 
Event or Problem Description
It was reported that a device fracture occurred.A vtcb/8.3 flexima was selected for use.During preparation, it was noted that the locking suture was broken.The procedure was completed with another of the same device.No complications reported and patient is stable.
 
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Brand Name
FLEXIMA
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8636639
Report Number2134265-2019-05662
Device Sequence Number13951280
Product Code FGE
UDI-Device Identifier08714729454953
UDI-Public08714729454953
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K023870
Number of Events Summarized1
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) 05/23/2019
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 Date07/31/2021
Device Model Number32337
Device Catalogue Number32337
Device Lot Number0022455166
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2019
Initial Report FDA Received Date05/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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