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

Catalog Number	CRUOS106
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.A device photo and a medical images was provided.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that the recanalization catheter allegedly became lodged in the distal cap of a proximal popliteal cto.It was further reported that as the health care provider pulled back on the recanalization catheter, the distal tip allegedly detached and remained in the cto.Reportedly, the hcp attempted to cross the lesion with an 0.035" guidewire but was unsuccessful.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records were 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.This is the only event reported to date for this lot number and failure mode.One partial recanalization catheter was returned with an 0.014" guidewire for evaluation.One photo and one image was also provided.A complete core wire fracture, tip detachment and catheter detachment were noted at the distal end of the catheter.Therefore, the investigation can be confirmed for the reported tip detachment.The root cause for the confirmed tip detachment could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that the recanalization catheter allegedly became lodged in the distal cap of a proximal popliteal cto.It was further reported that as the health care provider pulled back on the recanalization catheter, the distal tip allegedly detached and remained in the cto.Reportedly, the hcp attempted to cross the lesion with an 0.035" guidewire but was unsuccessful.There was no reported patient injury.

• 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: 7684094
• Report Number: 2020394-2018-01180
• Device Sequence Number: 10959843
• Product Code: PDU
• UDI-Device Identifier: 10801741125611
• UDI-Public: (01)10801741125611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: CRUOS106
• Device Lot Number: GFBY0943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1