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

Catalog Number CRUS6A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.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 Description

It was reported that after approximately three minutes of activation in the sfa / popliteal artery, a segment of the recanalization catheter allegedly detached.It was further reported that the recanalization catheter was removed and the detached segment was removed with a snare device without incident.Reportedly, the procedure was completed with another device.The patient was reported as doing well post procedure.

Event Description

It was reported that after approximately three minutes of activation in the sfa/popliteal artery, a segment of the recanalization catheter allegedly detached.It was further reported that the recanalization catheter was removed and the detached segment was removed with a snare device without incident.Reportedly, the procedure was completed with another device.The patient was reported as doing well post procedure.

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.The device was not returned.Therefore, the investigation is inconclusive for the alleged detachment as no objective evidence has been provided to confirm any alleged deficiency with the device.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 review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7870380
• MDR Text Key: 120100126
• Report Number: 2020394-2018-01687
• 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: 11/05/2018

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 Expiration Date: 03/28/2020
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFCQ1868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 122