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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 Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured. The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified brachial vein. A 6. 00 mm/2. 0cm/50cm otw peripheral cutting balloon catheter was selected for use. During the procedure, the balloon was inflated twice at 10atm within 15 seconds accordingly. However, at second inflation, it was noted that the balloon ruptured. The physician's comment was "the pressure was applied with an appropriate method, but a balloon rupture did not occur for the first time. However, a balloon rupture has occurred when the pressure was applied for the second time. " the device was removed without any problem using the normal method. The procedure was completed with another of the same device. No patient complications reported and the patient status 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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13120923
MDR Text Key283152407
Report Number2134265-2021-16366
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0025870963
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2020
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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