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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(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
The following information was reported: they were doing one last contrast run before treating with y90.As they were hand-injecting, they noticed leaking around hub.The potential problem is that y90 (yttrium) is radioactive and if the cantata had leaked with the y90 instead of contrast, the entire contents of the room could have become contaminated.The procedure was successfully completed with another cantata and there were no reported adverse effects as a result of this product problem.

• 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: 6993376
• Report Number: 1820334-2017-03806
• Device Sequence Number: 13776118
• Product Code: KRA
• UDI-Device Identifier: 10827002345826
• UDI-Public: (01)10827002345826(17)160901(10)4737647
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1