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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 Problems Break; Failure to Advance
Event Date 12/17/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that the shaft cracked. The 90% stenosed target lesion was located in the mildly tortuous vein. A 5. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, there was difficulty advancing the device to the lesion. Then, it was eventually able to cross; however, when inflation was performed, pressure of the indeflator did not increase. The device was simply pulled out from the patient's body. There were no fragments left inside the body. When it was checked, it was noted that the shaft became cracked. Puncture angle was nearly perpendicular, and it seemed that the catheter cracked when it had difficulty crossing the lesion. The procedure was completed with a different device. There was no patient complications reported and the patient was good post procedure.

 
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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 Key9553796
Report Number2134265-2019-16369
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 01/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24630
Device Catalogue Number24630
Device LOT Number0023750789
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 Received12/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/07/2019
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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