MAUDE Adverse Event Report: COOK INC CANTATA 2.9 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number	MCS-2.9-NT-135-15-HP
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/17/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
Prior to patient contact, the tech flushed the microcatheter and noticed that it was leaking where it connected to the hub.

• Brand Name: CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6990442
• Report Number: 1820334-2017-03401
• Device Sequence Number: 19155609
• Product Code: KRA
• UDI-Device Identifier: 10827002345826
• UDI-Public: (01)10827002345826(17)160901(10)4737677
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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 Catalogue Number: MCS-2.9-NT-135-15-HP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1