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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 24634
Device Problems Material Rupture (1546); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. Two 5. 00mm/2. 0cm/135cm peripheral cutting balloon and a 4. 00mm/1. 5cm/140cm small peripheral cutting balloon were selected for use. During the procedure, it was noted that the devices could not cross the lesion. Furthermore, balloon rupture occurred with all three devices. Physician's comment was "it was difficult to cross because there was a calcified lesion, but three devices of pcb were used and a balloon rupture has occurred on three devices. " the device was simply pulled out from the patient's body. The procedure was completed with another of the same device. No patient complications were reported and the patient was good 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 Key12729107
MDR Text Key279321340
Report Number2134265-2021-13526
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24634
Device Catalogue Number24634
Device Lot Number0027104010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
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: 11/01/2021 Patient Sequence Number: 1
Treatment
GUIDE CATHETER - NIPRO/CROSSROAD.
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