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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 12/10/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that the balloon ruptured. The 75% stenosed target lesion was located in the moderately tortuous cephalic vein. A 5. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, the balloon ruptured upon second inflation at 8atm for several seconds. The device was removed without problem and the procedure was completed. 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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9526560
MDR Text Key177142340
Report Number2134265-2019-16218
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/19/2021
Device MODEL Number24630
Device Catalogue Number24630
Device LOT Number0023373338
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2019
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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