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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 Device Dislodged or Dislocated
Event Date 04/05/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that blade was peeled off. The 90% stenosed target lesion was located in moderately tortuous left forearm shunt vein side. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, the balloon was inflated once at 6-10atm for 15 seconds. Consequently, after dilatation of the target lesion, it was noted that a part of the blade was peeled off. The device was simply removed from the patient's body and the balloon was still intact after removal. No components of the device was left inside the patient's body. 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 Key8556751
Report Number2134265-2019-04437
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2019
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 Number0022863561
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2018
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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