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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 Difficult to Remove ; Device Dislodged or Dislocated
Event Date 02/15/2019
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event- 18 years or older. (b)(6).

 
Event Description

It was reported that resistance was met upon removal and the blade was lifted. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. After dilatation was performed, resistance was met when the balloon was removed. Subsequently, the tip of the non-bsc introducer sheath got torn and one part of the blade became lifted. The procedure was completed with this device. No complications were reported and the patient's condition was good.

 
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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 Key8414252
Report Number2134265-2019-02261
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2019
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 Number21976565
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2019
Was Device Evaluated By Manufacturer? Yes
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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