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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U35130610
Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: one ultraverse035 pta dilatation catheter has returned for evaluation. No specific anomalies noted on the visual evaluation. On the functional evaluation the balloon catheter was inflated with the in-house presto device, upon inflation water was noted leak from the catheter near the strain relief. Under the microscopic observation a longitudinal tear was noted to the catheter. No further testing performed. Therefor the investigation was confirmed for the reported catheter leak, as the catheter leak during the functional evaluation. The investigation was also confirmed for the identified catheter tear as a longitudinal tear was noted to the catheter under microscopic observation. During the microscopic observation longitudinal tear was noted to the catheter was identified which leads to the reported leak. However, definitive root cause for the reported catheter leak and identified catheter tear could not be determined based upon the provided information. Labeling review: a review of product labeling documentation (e. G. , procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy. (expiry date: 03/2024).
 
Event Description
It was reported that during an angioplasty procedure, the shaft on the pta balloon allegedly leaked. The procedure was completed using another device. There was no reported patient injury.
 
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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 Key12966369
MDR Text Key281980517
Report Number2020394-2021-02049
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU35130610
Device Catalogue NumberU35130610
Device Lot NumberCMFR0120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
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

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