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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 Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the returned device was loaded onto a mandrel and attached to an encore inflation unit. Positive pressure was applied and a balloon pinhole leak was noted 12mm proximal of the proximal markerband. A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident. A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident. A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident. A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident. No issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 12-aug-2019. It was reported that balloon leakage occured. The target lesion was located in the iliac vein. A 10. 0 x 40, 75cm gladiator elite balloon catheter was advanced for dilatation. During the procedure, it was noted that the balloon was unable to maintain pressure and liquid was leaking. The procedure was completed with another of the same device. There were no patient complications nor injuries reported and the patient was stable. However, returned device analysis revealed a balloon pinhole.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8959416
MDR Text Key156442228
Report Number2134265-2019-10508
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809517
UDI-Public08714729809517
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/22/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0023231505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2019
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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