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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U3575610
Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had issues deflating.There was no reported patient injury.
 
Manufacturer Narrative
This supplemental emdr was sent to reflect the changes in the file, due to information received on 1/3/2019.Field b1, adverse event report type, was changed after receipt of new information, thus requiring a supplemental emdr within 30 days.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2021).
 
Event Description
It was reported that during an angioplasty procedure in the left superficial femoral artery, the pta balloon allegedly had issues deflating.A needle stick was used to puncture and deflation the device.Another device was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during an angioplasty procedure in the left superficial femoral artery, the pta balloon allegedly had issues deflating.A needle stick was used to puncture and deflation the device.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review:the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.During the visual inspection it was noted that the device was returned in two segments, and the balloon had a tear along its entire length.This damage will be considered incidental as they were not reported and would not have been present at the time of the procedure.Due to the condition of the sample the investigation is inconclusive for the reported deflation issue, as the device was unable to be functionally tested.Based on the evaluation results, the device was unable to be fully functionally tested due to the condition of the sample.Therefore, the definitive root cause for the reported deflation issues could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
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Brand Name
ULTRAVERSE 035 PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8162737
MDR Text Key130319785
Report Number2020394-2018-02204
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741092985
UDI-Public(01)00801741092985
Combination Product (y/n)N
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberU3575610
Device Catalogue NumberU3575610
Device Lot NumberCMCP0315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Date Manufacturer Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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