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

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.

• Brand Name: ULTRAVERSE PTA DILATATION CATHETER
• 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9440352
• MDR Text Key: 170544361
• Report Number: 2020394-2019-05356
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/09/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNK ULTRAVERSE
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/18/2019
• 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