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

Catalog Number	CXC4.8-3.7-35-135-P-NS-0
Medical Device Problem Codes	Hole In Material (1293); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation begun, but is not yet complete.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during a left lower extremity angioplasty procedure, the crosscath support catheter and a cook medical roadrunner pc hydrophilic wire guide crossed a mid superficial femoral artery (sfa) calcified chronic total occlusion (cto) and were advanced to the popliteal artery.A wire guide exchange to another manufacturer's 0.009 inch diameter rota wire guide was attempted; however, during advancement of the new wire guide, the wire protruded through the distal tip of the catheter and was unable to advance further.A kink/ hole was thought to be present at the end of the distal end of the catheter sidewall.The catheter and wire guide were simultaneously removed, and a new catheter and wire guide were utilized to cross the patient's lesion with no further issues.The procedure was able to be successfully completed.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the presence of four kinks, which were noted at distances of 0.2 cm, 0.6 cm, 1.0 cm, and 24 cm from the distal end of the device.A 0.035" wire was inserted into the proximal hub, and it became stuck at the kink at a distance of 24 cm from the distal end.With force, the wire was able to be advanced fully through the catheter.The device was leak tested using water and air, and no leaks were detected.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7328217
• Report Number: 1820334-2018-00563
• Device Sequence Number: 1592146
• Product Code: KRA
• UDI-Device Identifier: 00827002515819
• UDI-Public: (01)00827002515819(17)200915(10)8220853
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: CXC4.8-3.7-35-135-P-NS-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROADRUNNER HYDROPHILIC WIREBOSTON SCI. ROTA WIRE; ROADRUNNER HYDROPHILIC WIREBOSTON SCI. ROTA WIRE
• Patient Age: 74 YR