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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One crosscath support catheter was returned for evaluation.Three wire guides were stuck inside the catheter.Review of device history record shows two nonconforming events.There were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that state: "through a previously introduced, appropriately sized guiding catheter or sheath, insert the crosscath over an appropriately sized wire guide using standard technique.Under fluoroscopic guidance, carefully advance the catheter to the desired location, making sure that the wire guide tip extends beyond the catheter tip at all times.Final positioning is accomplished by short advances of the wire guide and catheter until the desired position is achieved and then confirmed by fluoroscopic visualization¿.Based on the information provided and results of the investigation, a definitive root cause could not conclusively be determined.Per the risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during a lower leg angiogram procedure, the wire became stuck and grabbed tissue during removal via the crosscath support catheter.A section of the device did not remain in the patient and there was no reported patient injury.

• 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: 6723642
• Report Number: 1820334-2017-02073
• Device Sequence Number: 187949
• Product Code: KRA
• UDI-Device Identifier: 00827002515772
• UDI-Public: (01)00827002515772(17)190627(10)7077272
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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 Model Number: N/A
• Device Catalogue Number: CXC3.4-2.2-18-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2017
• Initial Report FDA Received Date: 07/18/2017
• Patient Sequence Number: 1