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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 U357544
Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
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 been received for the evaluation. On the visual evaluation, the device was noted to be clean and no other specific anomalies were noted. On the functional evaluation, the guidewire lumen was flushed and the water was noted to be leaking from the inflation hub. On further, an in-house presto inflation device was used to inflate balloon but water was noted exiting from the guidewire hub. Balloon was cut and noted a slit to the inner guidewire lumen just proximal to the balloon, marker bands were also noted to be damaged and dislodged. No other functional testing performed. Therefore the investigation for the reported leak was confirmed, as the water was noted to be leaking from the inflation hub. The investigation for the identified inner guidewire lumen slit was also confirmed, as the slit was noted on the inner guidewire lumen of the balloon under the microscopic observation. The investigation for the identified marker band dislodgement was confirmed, as the marker bands were noted to be dislodged under the microscopic observation. A definitive root cause for the reported leak and the identified inner guidewire lumen slit, marker band dislodgement 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: 10/2023).
 
Event Description
It was reported that during an angioplasty procedure, the balloon allegedly leaked at hub. The procedure was completed by 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 Key12874581
MDR Text Key281337439
Report Number2020394-2021-01997
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 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU357544
Device Catalogue NumberU357544
Device Lot NumberCMEY0180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
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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