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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Advancement difficulties is addressed in the ifu.The event is currently under investigation.
Event or Problem Description
It was reported that the initial access of the chosen catheter site was too difficult and the physician had to move to the other leg.However, there was difficulty loading the catheter onto the wire and placement was aborted.During the removal process, when attempting to remove the catheter off the wire, the catheter locked on the wire and broke into three pieces.Reportedly none of the catheter broke off in the patient.The physician removed the wire and catheter out of the sheath and put in a new wire to complete the procedure.The wire tore the nurse¿s glove and scraped her hand but the customer did not confirm if any medical attention was administered, as this would depend on facility protocol.A section of the device did not remain inside the patient¿s body and the patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, functional test, drawings, device history record, manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the two returned device segments reported the proximal portion of the device to be measured at 139.4 cm in length from the strain relief.Elongation is noted starting at 120.7 cm and extending the length of the segment.Fraying is noted starting at 136.1 cm and extending the length of the segment.The distal portion of the device measured 33.5 cm in length.Fraying is noted starting at 136.1 cm and extending the length of the segment.The device is accordioning starting at 13.5 cm and extending the length of the segment.The 3 marker bands on this device are still intact.Both segments of the device were functionally tested with a 0.18 diameter wire guide.The proximal segment can be front loaded the entire length and back loaded 120.7 cm.The distal segment can be front loaded 16.5 cm and back loaded 16 cm.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, this device experienced significant force in order to remove the wire guide.This damage makes it difficult to determine the root cause of the failure mode.Possible causes for this failure mode include kinking or occlusion of the device.The root cause of this event is inconclusive.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
It was reported that the initial access of the chosen catheter site was too difficult and the physician had to move to the other leg.However, there was difficulty loading the catheter onto the wire and placement was aborted.During the removal process, when attempting to remove the catheter off the wire, the catheter locked on the wire and broke into three pieces.Reportedly none of the catheter broke off in the patient.The physician removed the wire and catheter out of the sheath and put in a new wire to complete the procedure.The wire tore the nurse¿s glove and scraped her hand but the customer did not confirm if any medical attention was administered, as this would depend on facility protocol.A section of the device did not remain inside the patient¿s body and the patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.

• 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: 5842622
• Report Number: 1820334-2016-00643
• Device Sequence Number: 18949223
• Product Code: KRA
• UDI-Device Identifier: 00827002515772
• UDI-Public: (01)00827002515772(17)180202(10)5621685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/07/2016

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?: No
• 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): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other