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 Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Code Available (3191)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 an angioplasty procedure, another manufacturer's guide wire perforated the side of the crosscath support catheter causing dissection of the patient's vessel.The patient's vessels were said to be calcified.Blood loss could not be quantified and blood transfusion was not reported.The physician surgically repaired the vessel.According to the initial reporter, no additional adverse events were reported as a result of this occurrence; however, the angioplasty procedure reportedly will need to be rescheduled for completion.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, documentation, drawing, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of kinks in the shaft of the device, which occurred at distances of 118.0 cm, 120.5 cm, 121.8 cm, 123.0 cm, 125.4 cm, 129.0 cm, and 131.7 cm from the proximal hub.There was also accordion damage noted at a distance of 118.0 cm from the proximal hub.One marker band was present at the location of the accordion damage, one marker band was present at the distal tip, and one marker band was missing.The distal end of the catheter was stretched.A wire guide was passed from the proximal hub with the stiff end first, and the wire advanced to the point of accordion damage.As the wire advanced, blood exited the catheter at the site of the accordion damage.The wire would not advance beyond the accordion damage.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, the root cause was determined to be a known inherent risk of the usage of the device.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigation findings.

• 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: 7496073
• Report Number: 1820334-2018-01226
• Device Sequence Number: 16226740
• Product Code: KRA
• UDI-Device Identifier: 00827002515819
• UDI-Public: (01)00827002515819(17)210123(10)8529108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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?: No
• 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: 04/17/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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: GLIDEWIRE ADVANTAGE (B)(4),TERUMO GLIDEWIRE (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 90