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

Model Number CRUS6A

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2022).

Event Description

It was reported that during a procedure, the device allegedly had a failure.There was no reported patient injury.

Event Description

It was reported that during a recanalization procedure, the core wire allegedly detached along with the marker band.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 6s crosser cto recanalization catheter was returned for evaluation.During visual evaluation, it was noted that the distal tip was detached from the catheter along with marker band and not returned.The inner core wire had a break approximately 4.1cm from the distal end of the catheter.No functional testing due to the condition of the sample.Therefore, the investigation is confirmed for the detachment of device or device component and corewire fracture.A definitive root cause for the detachment of device or device component and corewire fracture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2022).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 11669735
• MDR Text Key: 245524142
• Report Number: 2020394-2021-00855
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (y/n): N
• PMA/PMN Number: K161208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFEW2730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other