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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k122796.The event is currently under investigation.
Event or Problem Description
It was reported that during treatment of superior femoral artery stenosis and stenosis of the a.Tibialis anterior right side using a cxi support catheter, when wire was pulled out from the patient, the tip broke off.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A review of the complaint history, drawings, dimensional verification, 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 cxi support catheter was returned for investigation with 3mm of the distal tip separated from the rest of the catheter.The separated portion was frayed at one end.No notable damage other than the separated tip was observed.Catheter length, outer diameter, and distal tip length met dimensional requirements.In the device¿s returned condition, the distal hole diameter could not be measured with accuracy.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.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A review of the complaint history, drawings, dimensional verification, 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 cxi support catheter was returned for investigation with 3mm of the distal tip separated from the rest of the catheter.The separated portion was frayed at one end.No notable damage other than the separated tip was observed.Catheter length, outer diameter, and distal tip length met dimensional requirements.In the device¿s returned condition, the distal hole diameter could not be measured with accuracy.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.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.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: 6605756
• Report Number: 1820334-2017-01064
• Device Sequence Number: 606205
• Product Code: KRA
• UDI-Device Identifier: 00827002231627
• UDI-Public: (01)00827002231627(17)200306(10)7727190
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: CXI-2.3-14-135-ANG
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 79