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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 Problems Inflammation (1932); Thrombosis (2100); Vasoconstriction (2126)
Event Date 04/09/2020
Event Type  Injury  
Event Description
It was reported that balloon rupture occurred and the patient experienced swelling, vasospasm, and thrombosis. The patient presented for a percutaneous balloon catheter dilatation. The stenosed, 1. 5mm, target lesion was located in the internal fistula of the left forearm. Blood flow of the internal fistula was less than 160ml/min. A 6. 0 x40, 40cm gladiator elite balloon catheter was advanced for dilation. During the procedure, the physician first raised the pressure to 24pascal (pa) for 30 seconds but the color doppler ultrasound showed that the stenosis was not dilated. The physician dilated a second time and the color doppler ultrasound showed the stenosis still existed. When the physician increased the pressure to 24pa during the third dilation, the balloon position in the patient's vessel suddenly gave out a loud abnormal sound and it was noted that the pressure gauge of the inflation device returned to zero. The balloon was withdrawn and when saline was injected into the balloon, it was noted that there was an approximately 5mm fracture in the middle section of the balloon material. The patient had a slight swelling in the internal fistula, vasospasm and thrombosis, so the procedure was immediately stopped. The planned procedure was cancelled because of the issue, and the patient will accept another selective operation. The patient status was stable.
 
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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 Key9991985
MDR Text Key188979246
Report Number2134265-2020-05179
Device Sequence Number1
Product Code LIT
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 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024314490
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 Received04/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2019
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: 04/23/2020 Patient Sequence Number: 1
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