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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U41502H22
Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2021
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 ultraverse 014 pta dilatation catheter has returned into two segments for evaluation. On the visual evaluation of the returned segments, the first segment contains the catheter shaft and the y-body and the segment consist of balloon part which noted stuck within the balloon protector and stylet, the stylet was removed from the distal tip of the balloon and the balloon protector was made a cut to remove the balloon, it was further noted that the proximal marker band was noted to dislodge and not returned for evaluation. No other anomalies noted. All the anomalies noted on the microscopic observation. No further testing performed due to the condition of the device. Therefore, the investigation for reported leak remains inconclusive as no functional evaluation couldn¿t be performed due condition of the device. The investigation was confirmed the identified balloon detachment as the returned device noted to be detached into two segments. The investigation was also confirmed for balloon marker band dislodge as the proximal marker band noted to be dislodge from the balloon and not returned for evaluation. A definitive root cause for the reported leak, identified balloon detachment, balloon marker band dislodge 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: 12/2023).
 
Event Description
It was reported that during an angioplasty procedure, the device allegedly had a leak. The procedure was completed by using another device. There was no reported patient injury.
 
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Brand NameULTRAVERSE 014 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 Key12679201
MDR Text Key277909070
Report Number2020394-2021-01898
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU41502H22
Device Catalogue NumberU41502H22
Device Lot NumberCMFN0031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
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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