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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
A cxi support catheter was used in an 'up & over right leg angioplasty & would debridement" procedure.It was reported that the device snapped off while traveling through stenosis.15cm of cxi was left inside the patient.The patient did not require any additional procedures due to this occurrence and, 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, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One used cxi support catheter was returned for investigation.Damage is noted 23.5 cm to 25.7 cm from the proximal end.Damage is also noted at 45.0 cm.A kink is noted at 85.2 cm.The distal tip is frayed.No damage to the hub or strain relief.In the devices used returned condition, the device length dimension did not meet specification.A document-based investigation was performed.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 were no other reported complaints for this lot number.Each device is distributed with instructions for use (ifu) t_cxi_rev5 which states: ¿the catheter should not be advanced through and area of resistance unless the source of the resistance is identified by fluoroscopy and the appropriate steps are taken and to reduce or remove the obstruction¿.Based on the information provided, and the results of our investigation there is no definitive root cause.Per the quality engineering risk assessment, no further action is required.The 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: 6791815
• Report Number: 1820334-2017-02495
• Device Sequence Number: 1570091
• Product Code: KRA
• UDI-Device Identifier: 00827002525436
• UDI-Public: (01)00827002525436(17)190926(10)7304121
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-4.0-35-135-P-NS-DAV
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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
• Patient Age: 79 YR