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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred. The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right superficial femoral artery. A 5. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, at second inflation, it was noted that the balloon ruptured at 10atm for 10 seconds. The device was simply removed from the patient's body and procedure was completed with another of the same device. No patient complications were reported.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key9357384
MDR Text Key173757702
Report Number2134265-2019-14282
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/13/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023180772
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 Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2019
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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