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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4150210RX
Device Problems Material Separation (1562); Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
It was reported that during preparation for an angioplasty procedure, the guidewire allegedly was unable to insert into the guidewire lumen. There was no patient contact.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: one ultraverse rx device was received for evaluation, the device guidewire lumen was attempted to be flushed but was unsuccessful. An inhouse guidewire was attempted to be inserted but was unable to be fully inserted. The device was cut and under microscopic examination an unknown object was noted within the guidewire lumen. The material was noted to likely be the inner most layer of the inner lumen separating from the catheter. Therefore, the investigation is confirmed for the reported guidewire insertion issue, as a device guidewire was unable to be fully inserted through the device. The investigation is also confirmed for the identified material separation, as the inner lumen was noted to be separated and blocking the guidewire lumen. The definitive root cause of the identified material separation and guidewire insertion issue could not be determined based upon the available 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: 04/2023).
 
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Brand NameULTRAVERSE RX
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 Key12981973
MDR Text Key282116507
Report Number2020394-2021-02063
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131199
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
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150210RX
Device Catalogue NumberU4150210RX
Device Lot NumberCMES0417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2020
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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