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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accordion effect on the device has been determined not reportable.This report is for the separated condition in which the device was received by the manufacturer.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.
Event or Problem Description
It was reported that during a left leg angiogram, a v18 guide wire was used inside a crosscath support catheter to advance through the lesion toward the target area.The physician noticed buckling of the catheter and decided to exchange catheters.When pulling the crosscath support catheter back out of the patient, the catheter would not slide back over the wire; they were essentially stuck together.In order to maintain purchase with the wire, a portion of the catheter was cut open and pealed back in an attempt to separate the two.However, that is when they noticed the accordion-like effect on the catheter.Eventually both the wire and catheter were removed from the patient together.The device was returned to the manufacturer; upon inspection, it was found to be separated at the strain relief.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used crosscath support catheter was returned for investigation.A wire guide is attached to the entire length of the catheter.Strain relief and hub are separated from the catheter.No damage is noted to the hub or the strain relief.None of the catheter is noted inside the hub or strain relief.The catheter is separated in two segments.Three marker bands are present, but are separated from segment one of the catheter.Hydrophilic coating is present on the catheter.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during a left leg angiogram, a v18 guide wire was used inside a crosscath support catheter to advance through the lesion toward the target area.The physician noticed buckling of the catheter and decided to exchange catheters.When pulling the crosscath support catheter back out of the patient, the catheter would not slide back over the wire; they were essentially stuck together.In order to maintain purchase with the wire, a portion of the catheter was cut open and pealed back in an attempt to separate the two.However, that is when they noticed the accordion-like effect on the catheter.Eventually both the wire and catheter were removed from the patient together.The device was returned to the manufacturer; upon inspection, it was found to be separated at the strain relief.Follow-up with the physician revealed that the separation occurred while the catheter was halfway out of the leg.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not 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: 6563112
• Report Number: 1820334-2017-00950
• Device Sequence Number: 10784054
• Product Code: KRA
• UDI-Device Identifier: 00827002515772
• UDI-Public: (01)00827002515772(17)191026(10)7388940
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 75