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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A cxi support catheter was used in a re-do by-pass with graft/right iliac seating.It was reported that the tip of the catheter fully separated during the procedure.It was further reported that the tip was retrieved separately from the catheter, the entire component was removed without any harm.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, dimensional verification, device history record, documentation, quality control, visual inspection and functional testing of the returned device was conducted during the investigation.One used cxi support catheter was returned for investigation.The catheter is separated into two sections.Proximal section is 73.4 cm in length.The distal section is 15.4 cm in length.The total length is 88.8 cm which is in specification.Both ends of the catheter at the separation site are frayed.The catheter force at break meets requirements.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record shows one non-conforming event that is not related to the reported failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6953556
• Report Number: 1820334-2017-03554
• Device Sequence Number: 1141286
• Product Code: KRA
• UDI-Device Identifier: 00827002525467
• UDI-Public: (01)00827002525467(17)200124(10)7617358
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072724
• 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): 01/10/2018

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 Model Number: N/A
• Device Catalogue Number: CXI-4.0-35-90-P-NS-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Required Intervention