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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 H74939207050270
Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental mdr will be filed. (b)(4).
 
Event Description
It was reported that balloon tear occurred. During unpacking of a 5. 0 x20 75cm gladiator¿ balloon catheter, it was noted that there was a slit on the balloon material. The procedure was completed with another of the same device. No patient complications were reported.
 
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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 Key7538374
MDR Text Key109108905
Report Number2134265-2018-04487
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113681
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 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/27/2021
Device Model NumberH74939207050270
Device Catalogue Number3920705027
Device Lot Number0021921112
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 Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
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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