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

Model Number	CRUS6106
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one crosser s6 catheter was returned and evaluated.During visual inspection a detached core wire and tear in the outer shaft were noted approximately 0.5 cm from the distal tip.Therefore, the investigation can be confirmed for detachment and torn material.The root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 12/2020).
Event or Problem Description
It was reported that during preparation for a recanalization catheter procedure, the catheter tip allegedly appeared to be deformed.It was further reported that another recanalization catheter was used to complete the procedure.There was no patient contact.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11302751
• Report Number: 2020394-2021-80155
• Device Sequence Number: 12001688
• Product Code: PDU
• UDI-Device Identifier: 10801741125642
• UDI-Public: (01)10801741125642
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: Health Professional
• Device Model Number: CRUS6106
• Device Catalogue Number: CRUS6106
• Device Lot Number: GFDN0388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1