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

Catalog Number CRUS6A

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.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: 12/28/2019).

Event Description

It was reported that during treatment of a chronic total occlusion in the left anterior and popliteal artery, the tip of the recanalization catheter would not pass through the support catheter.Another recanalization catheter was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during treatment of a chronic total occlusion in the left anterior and popliteal artery, the tip of the recanalization catheter would not pass through the support catheter.Another recanalization catheter was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.This is the only complaint reported to date for this lot number and failure mode.One crosser s6 catheter was returned for evaluation.The distal tip was not in alignment with the proximal segment of the catheter.The core wire was fractured near the distal tip.A partial circumferential break was identified approximately 0.4cm from the distal tip.Therefore, the investigation is confirmed for an outer catheter break and a fractured corewire.As functional testing could not be performed, the investigation is inconclusive for device-device incompatibility.It is possible that additional force was applied in an attempt to advance the crosser catheter through the usher support catheter which may have caused the fractured corewire and outer catheter break.The definitive root cause could not be determined based on the available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).(expiry date: 12/2019).

• Brand Name: CROSSER RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7993747
• MDR Text Key: 124671328
• Report Number: 2020394-2018-01926
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFCN1982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 88