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

Model Number	CRUOS106
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Two photos and one crosser 14s were returned for evaluation.Review of the photos revealed a crosser catheter with separation of the outer sheath and guide wire lumen from the distal tip.Additionally, evaluation of the returned device revealed material separation of the outer sheath and guide wire lumen from the distal tip.Based on review of the photos and returned device, the investigation is confirmed for material separation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model cruo14sa recanalization catheter allegedly experienced the tip of the catheter separating from the distal tip, with the core wire holding the tip intact.The procedure was completed with device.This report was received from one source.This event involved one male patient, (b)(6) years of age and approximately (b)(6) kgs.This patient had no reported patient injury.

• 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: 8491718
• Report Number: 2020394-2019-00251
• Device Sequence Number: 16472626
• Product Code: PDU
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• 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): 04/08/2019

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: CRUOS106
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFCT2400
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1