MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD CROSSER CTO RECANALIZATION CATHETER; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Catalog Number CRUS6A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

A 4mm tip of cto recanalization catheter ultrasound tip sheared off and became imbedded in calcified plaque in occluded left iliac artery.Fda safety report id # (b)(4).

• Brand Name: BARD CROSSER CTO RECANALIZATION CATHETER
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 9671202
• MDR Text Key: 177966204
• Report Number: MW5092746
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2020

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 Expiration Date: 08/28/2021
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFDV0756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 72