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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 Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2021
Event Type  Injury  
Event Description
It was reported that blade detachment occurred. The 75% stenosed target lesion was located in the moderately tortuous basilic vein upperarm-underarm. A 5. 00mmx2. 0cmx50cm peripheral cutting balloon was selected for use. During the procedure, the lesion was dilated twice at 8 atmospheres with this device, and the loop graph and anastomosis were dilated once with 8 atmospheres. After dilation, resistance was felt during removal. So the physician went a little further and this device was dilated to 6 atmospheres once. Then, removal was tried again and it was able to be removed smoothly. When removed, it was found that one blade was missing. The blade was checked on the fluoroscopy and it was found stuck in the upper arm - armpit area. An incision was made in the brachial vein and forceps were used to try to grab it, but it was unable to be retrieved. Then, a 12mm mustang balloon catheter was used and dilated next to the blade and a gooseneck snare was used to grab the mustang together with the blade and the whole thing was pulled out. When the recovered blade was closely inspected, it seems to be bent in one direction or another. The procedure was completed without any device replacement. No patient complications were 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 Key11568923
MDR Text Key242257314
Report Number2134265-2021-03749
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
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2022
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0026464286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2020
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: 03/25/2021 Patient Sequence Number: 1
Treatment
GUIDEWIRE - 018GW; INTRODUCER SHEATH - VAIVT ACE 6F3CM
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