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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 Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : gladiator elite device was returned for analysis. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. Blood was observed in the balloon body indicating presence of a leak. The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at approximately 12 mm from the proximal end of the proximal markerband. The rated burst pressure for this device is 14 atmospheres. A visual and microscopic examination observed no issues with the tip of the device which could potentially have contributed to the complaint incident. A visual and tactile examination found no kinks or damage along the shaft of the device. No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 06-nov-2019. It was reported that balloon leak occurred. The target lesion was located in a cephalic arch vein. A 10. 0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation. However, during inflation, the balloon contrast leaked out of the distal part of the balloon. They immediately removed the balloon for inspection. Once outside of the body, the balloon was put in the saline bowl and inflated and was noted that the balloon was leaking contrast from the distal portion. The procedure was completed with another of the same device. No patient complications were reported. However, 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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9378362
MDR Text Key173776549
Report Number2134265-2019-14068
Device Sequence Number1
Product Code LIT
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
Report Date 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024091506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2019
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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