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

Model Number CRUO14SA

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cruo14sa recanalization catheters allegedly experienced detachment and failure to advance.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.

Manufacturer Narrative

H 10: for the reported event, lot number was provided, and lot history review was performed.The sample was returned for evaluation.Investigation of the returned device confirmed tip detachment however, remains inconclusive for advancement failure.The definite root cause could not be determined based on the available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cruo14sa recanalization catheters allegedly experienced detachment and failure to advance.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was 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
• MDR Report Key: 10284919
• MDR Text Key: 199254217
• Report Number: 2020394-2020-04505
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CRUO14SA
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFDV2746
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1