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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 U351301210
Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2021
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 return of the sample is pending. However, photos were provided for review. The investigation of the reported event is currently underway. (expiry date: 01/2024).
 
Event Description
It was reported that during an angioplasty procedure of stenotic and occluded area in the right iliac-femoral vein, the pta balloon allegedly ruptured at 8 atm. It was further reported that during the retrieval of balloon into the sheath the balloon shaft allegedly broke and had difficulty in retracting the balloon thru the introducer sheath. The procedure was completed using another balloon. There was no reported patient injury.
 
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Brand NameULTRAVERSE 035 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 Key12932112
MDR Text Key281742580
Report Number2020394-2021-02035
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
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 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU351301210
Device Catalogue NumberU351301210
Device Lot NumberCMFP0175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2021
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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