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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 24628
Device Problem Device Dislodged or Dislocated
Event Date 08/22/2018
Event Type  Malfunction  
Event Description

It was reported that blade lifted occurred. The target lesion was located in the shunt. An 8. 00mmx2. 0cmx50cm peripheral cutting balloon was used for percutaneous transluminal angioplasty. During withdrawal, it was noted that the blade came partially off from balloon after it was pulled back from the sheath. The procedure was completed with this 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 IRELAND LIMITED
ballybrit business park
,
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
,
maple grove , MN 55311
6515827403
MDR Report Key7883265
Report Number2134265-2018-61091
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/24/2019
Device MODEL Number24628
Device Catalogue Number24628
Device LOT Number0020199811
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 Received09/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2017
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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