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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U41502H30
Device Problems Peeled/Delaminated (1454); Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
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 as well as photos were provided for review. The investigation of the reported event is currently underway. Expiration date: (expiry date: 04/2022).
 
Event Description
It was reported that during preparation for an angioplasty procedure, the pta balloon was allegedly damaged. It was further reported that another balloon was used to complete the procedure. There was no reported patient contact.
 
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Brand NameULTRAVERSE 014 PTA DILATATION CATHETER
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 Key12587765
MDR Text Key275151033
Report Number2020394-2021-01837
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU41502H30
Device Catalogue NumberU41502H30
Device Lot NumberCMDS0464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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