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

Model Number	CRUS6A
Medical Device Problem Code	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
The lot number was provided for both malfunctions and lot history reviews were done.The device has been returned for evaluation for one of the two malfunctions; the evaluation identified detachment.The device has not been returned for the second malfunction; the investigation is inconclusive for detachment as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model crus6a recanalization catheter allegedly experienced a detachment.This information was received from various sources.Both malfunctions involved patients with no reported consequences.One patient was reported as a (b)(6)-year-old male; all other patient details were 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: 9582066
• Report Number: 2020394-2020-00190
• Device Sequence Number: 13567482
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• 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
• Report Date (Section B): 01/13/2020

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: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFDP3807
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1