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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-Device Incompatibility (2919)
Patient Problem Blood Loss (2597)
Event Date 03/06/2020
Event Type  Injury  
Event Description
It was reported that blades of the cutting balloon cut the patient during removal. The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, pre dilation was performed using a 3mm-20mm and 5mm-40mm after the guidewire was crossed and then this device was used. The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds. Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted. As per physician, the blade cut the skin at the puncture sit which made the site expanded. The procedure was completed with a different device. There were no patient complications 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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9888381
MDR Text Key187708376
Report Number2134265-2020-03967
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0024476257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2019
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: 03/27/2020 Patient Sequence Number: 1
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