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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 Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the guidewire extended outside the catheter. The 50% stenosed target lesion was located in the moderately tortuous and non-calcified shunt vessel. A 6. 00mm/ 2. 0cm/ 50cm peripheral cutting balloon was selected for use. During the procedure, it was noted that the device was successfully inflated. However, when the guidewire was inserted in the catheter again, it came out of the balloon catheter from the proximal area of the balloon. The procedure was completed with another of the same device. There were no 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 Key13310704
MDR Text Key284692799
Report Number2134265-2022-00438
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027851105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2021
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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