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

Model Number	CRUO14SA
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10284919
• Report Number: 2020394-2020-04505
• Device Sequence Number: 16797830
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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
• Operator of Device: No Information
• Device Model Number: CRUO14SA
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFDV2746
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1