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

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER

  • 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
 

BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U3575530
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/28/2022
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 05/2023).
 
Event Description
It was reported that during an angioplasty procedure through the superficial femoral artery to treat the lower limb, the distal part of the balloon caught on the sheath and was unable to remove from the patient after deflation. It was further reported that physician pulled the balloon from the patient very hard which caused the arterial damage. Another sheath was used to tamponade the damaged artery and the patient was reported to be in stable condition.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 05/2023).
 
Event Description
It was reported that during an angioplasty procedure through the superficial femoral artery to treat the lower limb, the distal part of the balloon caught on the sheath and was unable to remove from the patient after deflation. It was further reported that physician pulled the balloon from the patient very hard which caused the arterial damage. Another sheath was used to tamponade the damaged artery and the patient was reported to be in stable condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAVERSE 035
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13598536
MDR Text Key286167587
Report Number2020394-2022-00128
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU3575530
Device Catalogue NumberU3575530
Device Lot NumberCMET0496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
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: 02/25/2022 Patient Sequence Number: 1
-
-