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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number UNK ULTRAVERSE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Perforation (2001); Thrombosis (2100)
Event Date 06/09/2019
Event Type  Injury  
Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: chen, j. X. , levin, l. S. , mantell, m. P. , redmond, j. W. , & clark, t. W. I. (2019). Endovascular therapy for below-the-elbow arterial disease: an initial single-center experience. Journal of endovascular therapy, 26(4), 505¿511. Doi: 10. 1177/1526602819854167.

 
Event Description

It was reported in an article from the journal of endovascular therapy titled " endovascular therapy for below-the-elbow arterial disease: an initial single-center experience " that complications were observed in a retrospective review of the 19 patients who underwent angioplasty for critical limb ischemia. Postangioplasty, there were 3 access site hematomas and one perforation in the axillary artery, which resolved with balloon tamponade. Rethrombosis of the radial artery within hours of endovascular revascularization due to postprocedural heparin not being initiated appropriately; the patient underwent subsequent successful surgical thrombectomy. A technical failure was observed in 3 procedures; the patient underwent subintimal recanalization using a variety of crossing devices, however, reocclusion occurred in 3 weeks later. The status of the patients was not provided.

 
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Brand NameULTRAVERSE 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
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9440352
MDR Text Key170544361
Report Number2020394-2019-05356
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ULTRAVERSE
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/09/2019 Patient Sequence Number: 1
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