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

Catalog Number	CXI-2.6-18-150-P-NS-0
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/03/2018
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, during an unspecified peripheral intervention procedure, another manufacturer's guidewire had difficulty passing through the cxi support catheter.The physician was attempting to access the patient's occluded superficial femoral artery using another manufacturer's guidewire through the complaint device and was unable to flush contrast.Subsequently, the physician attempted to insert another guidewire of the same type.This guidewire was not able to pass through the complaint device.Both devices were removed and the physician aborted the procedure at this point.During follow up, it was reported the physician had not yet re-scheduled the procedure.If the patient agrees, a bypass will be performed.No adverse effects have been reported to date.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The inspection of the returned device confirmed that the wire guide would not progress through the catheter.A sample 0.018" wire guide checker was passed through the distal tip, and resistance was met at a distance of 43.0 cm, and would not progress through the proximal hub.Additionally, upon removing the strain relief, a kink was noted 2.0 cm from the proximal hub.When the strain relief was replaced, a second kink was noted at a distance of 59.5 cm, a third kink was noted at 111.0 cm, and a fourth kink was noted at 137.4 cm from the proximal hub of the device.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: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7698717
• Report Number: 1820334-2018-02078
• Device Sequence Number: 1329915
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)190928(10)7311375
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Device Lot Number: 7311375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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: BOSTON SCIENTIFIC V-18 WIREGUIDE; BOSTON SCIENTIFIC V-18 WIREGUIDE
• Outcome Attributed to Adverse Event: Other