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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4150330
Device Problems Material Rupture (1546); Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure, the balloon was allegedly unable to cross lesion. There was no reported patient injury.
 
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 ultraverse 014 pta dilatation catheter was returned for evaluation. Balloon twisting was able to be observed on the retuned device. No other specific anomalies noted during the visual evaluation. On the functional evaluation, the guide wire lumen was flushed and an in-house guide wire was able to insert and remove through the catheter without any issue. Further, the balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the balloon. Under microscopic observation it was noted a longitudinal rupture. No further testing was performed. Therefore, the investigation for reported unable to cross lesion remains inconclusive as the condition of use could not be reproduced on the laboratory condition. However, the investigation was confirmed for an identified balloon twist as the twisted balloon was able to observe during the visual evaluation of the returned sample. The investigation was also confirmed for identified balloon rupture as a longitudinal balloon rupture was observed under the microscope and water also leaks from the balloon during the functional testing. A definitive root cause for the reported unable to cross lesion, identified balloon twist and balloon rupture 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.
 
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Brand NameULTRAVERSE 014
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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key14600024
MDR Text Key293331932
Report Number2020394-2022-00437
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150330
Device Catalogue NumberU4150330
Device Lot NumberCMDV0159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
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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