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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 U4150230RX
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2022
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 rx pta dilatation catheter was returned for evaluation. No kinks noted to the catheter shaft; no other anomalies noted on the inflation luer. Under microscopic observation it was observed that the inner guide wire lumen was kinked at the proximal end of the balloon. No functional testing was performed due to the condition of the device. Therefore, the investigation for the reported unable to cross lesion remains inconclusive as the conditions of use could not be replicated in laboratory conditions. However, the investigation was confirmed for material deformation as the inner guide wire lumen was noted to be kinked and was observed during the microscopic observation. A definitive root cause for the reported unable to cross lesion and kink 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 of a highly calcified target lesion below the knee, the pta balloon was allegedly unable to cross the lesion. It was further reported that the catheter shaft was allegedly kinked. The procedure was completed using another device. 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 rx pta dilatation catheter was returned for evaluation. No kinks noted to the catheter shaft; no other anomalies noted on the inflation luer. Under microscopic observation it was observed that the inner guide wire lumen was kinked at the proximal end of the balloon. No functional testing was performed due to the condition of the device. Therefore, the investigation for the reported unable to cross lesion remains inconclusive as the conditions of use could not be replicated in laboratory conditions. However, the investigation was confirmed for material deformation as the inner guide wire lumen was noted to be kinked and was observed during the microscopic observation. A definitive root cause for the reported unable to cross lesion and kink 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 of a highly calcified target lesion below the knee, the pta balloon was allegedly unable to cross the lesion. It was further reported that the catheter shaft was allegedly kinked. The procedure was completed using another device. There was no reported patient injury.
 
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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 Key13511945
MDR Text Key285463365
Report Number2020394-2022-00094
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 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150230RX
Device Catalogue NumberU4150230RX
Device Lot NumberCMEY0594
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
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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