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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this report indicate the information is unknown or unavailable.(b)(4).Event is still under investigation at this time.
Event or Problem Description
Information initially provided on (b)(6) 2016 stated: "snapped in two during pedal case." additional information was requested on (b)(6) 2016.The complaint product was received (b)(6) 2016 and it was noted that the distal end of the catheter was missing.Additional information was again requested (b)(6) 2016 and was informed the physician was out of the country.A response was provided (b)(6) 2016 and it was at that time, the event was determined reportable.Although the customer did not state the catheter snapped within the patient, the manufacturer was advised that during a peripheral leg-pedal access and femoral artery access procedure on the (b)(6) male patient, with severe calcified artery and pre-existing condition of pad, the device "snapped in two." the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation- the proximal portion of the reported device returned for evaluation; the distal segment of the device was not returned.Visual inspection off the return portion noted damage starting at 121 cm from the strain relief.The catheter was noted to have kinks and signs of elongation for the next 9 cm.The noted damage is indicative of excess force applied to the catheter during usage.A review of the complaint history, device history record, ifu, quality control and visual inspection of the returned device was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

• 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: 6101711
• Report Number: 1820334-2016-01347
• Device Sequence Number: 10932915
• Product Code: KRA
• UDI-Device Identifier: 00827002515741
• UDI-Public: (01)00827002515741(17)170301(10)4869234
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2016

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 Model Number: N/A
• Device Catalogue Number: CXC3.0-1.9-14-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 81