MAUDE Adverse Event Report: COOK INC CROSSCATH SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number	CXC3.0-1.9-14-135-P-NS-0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2016
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
As reported to customer relations, the wire accordioned inside catheter.A different wire was used but the same thing happened.The catheter and wire were pulled out and catheter had bunched up on the wire.Also, the hub broke.A new catheter and wire were used to finish the procedure as normal.There were no issues with the new catheter.Additional information provided indicated that the second wire that was opened was from the same lot number.According to the district manager, there were no additional procedures, no adverse effects reported.The hub of the catheter broke off, but it did not remain in the patient.

• Brand Name: CROSSCATH SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6987968
• Report Number: 1820334-2017-03393
• Device Sequence Number: 13575388
• Product Code: KRA
• UDI-Device Identifier: 00827002515734
• UDI-Public: (01)00827002515734(17)190603(10)7020547
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: CXC3.0-1.9-14-135-P-NS-0
• 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: 10/30/2017
• Patient Sequence Number: 1
• Patient Age: 56 YR