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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 Failure to Advance (2524); Device Damaged by Another Device (2915)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/28/2020
Event Type  Injury  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that there was bleeding and slit on sheath. Vascular access was obtained via ipsilateral approach. The 95% stenosed target lesion was located in the moderately calcified popliteal artery. A 6. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon was selected for use. During procedure, the device was advanced after a guidewire passed through. However, the device had difficulty in crossing the lesion thus pre-dilation was performed with cob. The device was delivered again and dilatation was performed repeatedly for several times. Subsequently, bleeding was observed in the subcutaneous femoral when the sheath was removed. The blade of the balloon slit the sheath over its entire length in one direction causing the blood leaked. The bleeding was arrested by astriction. Per physician's opinion, the bleeding was caused by the balloon blade. The procedure was completed with this device. No further complications reported and patient was stable post procedure.

 
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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 Key10437043
MDR Text Key203991784
Report Number2134265-2020-11436
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24630
Device Catalogue Number24630
Device LOT Number0025510578
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2020
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: 08/21/2020 Patient Sequence Number: 1
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