• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24628
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a blade was missing. The 75% stenosed target lesion was located in the moderately tortuous cephalic vein. A 6. 00mm/ 2. 0cm/ 50cm peripheral cutting balloon was selected for use. During procedure, dilatation was performed twice at 10 atm around the cephalic vein anastomosis (the angle was gently/slowly applied). The device was simply removed since the lesion area was properly expanded. However, one out of the four blade was missing even if excessive force more than usual was not used. The procedure was completed with this device. There were no complications reported and there was no problem with the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9903123
MDR Text Key185944168
Report Number2134265-2020-04092
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024884443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2019
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: 03/31/2020 Patient Sequence Number: 1
-
-