MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS

Model Number CRUS6A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged detachment issue.The root cause could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model crus6a, recanalization catheter, allegedly experienced detachment of device or device component.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9963757
• MDR Text Key: 189200982
• Report Number: 2020394-2020-02721
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

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: No Information
• Device Model Number: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFDV0756
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1