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

MAUDE Adverse Event Report: EV3 INC. RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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
 

EV3 INC. RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number A14BX020060170
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
While performing an intervention on an arterial lower extremity chronic total occlusion, an angioplasty balloon was inflated within the lesion.At some point thereafter, the physician was attempting to remove the balloon and it became detached from the shaft (catheter) within the artery.Device remains in patient.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
EV3 INC.
plymouth MN 55442
MDR Report Key13001998
MDR Text Key282325106
Report NumberMW5106011
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2024
Device Model NumberA14BX020060170
Device Lot NumberB214038
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
Patient SexMale
Patient Weight81 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
-
-