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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 02/04/2019
Event Type  Malfunction  
Event Description

It was reported that the blade was lifted. A 2cm peripheral cutting balloon (pcb) was used in a shunt percutaneous transluminal angioplasty (pta) procedure. During procedure, after performing balloon dilation at nominal pressure for three times, the balloon was removed from the sheath. Subsequently, it was noted that the blade became lifted from the balloon. The device was then simply puled out from the patient's body and it was confirmed that the balloon did not detach from the balloon. No complications were reported and the patient's condition post procedure 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 Key8374076
Report Number2134265-2019-01732
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24628
Device Catalogue Number24628
Device LOT Number0022937041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/27/2019 Patient Sequence Number: 1
Treatment
INTRODUCER SHEATH- GP6F3CM
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