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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4200215RX
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2020
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 return of the sample is pending. The investigation of the reported event is currently underway. (expiry date: 06/2021). Device pending return.

 
Event Description

It was reported that during an angioplasty procedure, the hydrophilic coating on the device allegedly comes off on the gloves. There was no reported patient injury.

 
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Brand NameULTRAVERSE RX 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 Key10893549
MDR Text Key217940424
Report Number2020394-2020-20572
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberU4200215RX
Device Catalogue NumberU4200215RX
Device LOT NumberCMCU0484
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/24/2020 Patient Sequence Number: 1
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