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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939207070470
Device Problems Balloon; Material Rupture; Torn Material
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported via facility medwatch# 5068969 that balloon rupture and balloon tear occurred. The target lesion was located in the distal cephalic vein. A 7. 0 x40, 75cm gladiator¿ balloon catheter was advanced for dilation. However, during inflation, the balloon ruptured in the middle into two pieces. When the device was removed, it was noted that the distal half of the balloon stayed inside the fistula over a wire. The detached balloon was then snared out of the patient. No further patient complications were reported.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that the balloon was inflated at 26 atmospheres and the procedure was completed with a different device.

 
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Brand NameGLADIATOR¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6567669
Report Number2134265-2017-04657
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/10/2020
Device MODEL NumberH74939207070470
Device Catalogue Number3920707047
Device LOT Number20143685
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/15/2017 Patient Sequence Number: 1
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