• 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 Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2020
Event Type  Injury  
Event Description
It was reported that the balloon failed to deflate and was difficult to remove. A 6. 00mm/2. 0cm/50cm peripheral cutting balloon was selected for a percutaneous transluminal angioplasty (pta) of shunt anastomosis. Successful dilation of the lesion was performed using the device. Vacuum was applied to remove from the patient. The balloon was not folded back into original position and was unable to be removed from the patient. One of the cutting balloon blades became stuck at the tip of the non-bsc 6f sheath. The balloon and sheath were surgically removed. The patient's status was fine.
 
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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10549051
MDR Text Key207398637
Report Number2134265-2020-12851
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/26/2022
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0025536289
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
Treatment
SHEATH: CORDIS 6FR
-
-