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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 U41502H15RX
Device Problems Inflation Problem (1310); Leak/Splash (1354); Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2023
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure of a highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported that the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 10/2024).
 
Manufacturer Narrative
H10: 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 received for evaluation.During visual evaluation, multiple kinks throughout the catheter shaft and bunching of the balloon were observed.The sample was inadvertently severed into two segments and thus functional testing couldn't be performed.Therefore, the investigation is confirmed for the reported material deformation as multiple kinks throughout the catheter shaft and bunching of the balloon were observed.However, the investigation is inconclusive for the reported inability to cross lesion and leak as functional testing could not be performed.A definitive root cause for the alleged inability to cross lesion, material deformation and leak 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.H10: (expiration date: 10/2024).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during an angioplasty procedure of a highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.There was no reported patient injury.
 
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Brand Name
ULTRAVERSE RX
Type of Device
PTA 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 Key16653011
MDR Text Key312688443
Report Number2020394-2023-00212
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741056628
UDI-Public(01)00801741056628
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 Physician
Type of Report Initial,Followup
Report Date 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberU41502H15RX
Device Catalogue NumberU41502H15RX
Device Lot NumberCMFY0121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2023
Initial Date FDA Received03/30/2023
Supplement Dates Manufacturer Received04/25/2023
Supplement Dates FDA Received04/27/2023
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
Patient Sequence Number1
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