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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24686
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The target lesion was located in the cephalic arch vein. A 10. 0 x40, 75cm gladiator balloon catheter was advanced for dilatation. However, during initial inflation at 14 atmospheres, the balloon ruptured. The device was removed and no patient complications were reported.
 
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Brand NameGLADIATOR ELITE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10049103
MDR Text Key191011481
Report Number2134265-2020-06367
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809517
UDI-Public08714729809517
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024711812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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