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

Catalog Number	CXI-4.0-35-150-P-NS-DAV
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: concomitant products: microcatheter(corsair armet / asahi intercc), wire guide(cruise / asahi intecc), 0.014 wire guide (halberd), 0.035inch (radifocus / terumo).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, a female patient with a history of peripheral artery disease underwent endovascular therapy (evt) of the left common femoral artery (cfa) via contralateral approach from the right cfa.Upon removal of the cxi support catheter from the patient's anatomy, the tip was noted to be elongated.During initiation of the evt procedure, another manufacturer's guiding catheter was advanced to the contralateral side from the right cfa.The physician attempted to make the combination of a another manufacturers' microcatheter and wire guide run through a chronic total occlusion (cto) which existed on the way to the target lesion.However, it did not cross the cto.The wire guide was exchanged for another, the result was the same.Therefore, the microcatheter was changed to the complaint cxi support catheter along with another manufacturer's wire guide.Attempts to make the combination of the complaint device and the wire guide pass through the cto was conducted by using a knuckle wire technique but, it was felt the tip of the complaint device was getting stuck on the cto during that attempt.Thus, it was removed out of the patient's anatomy and the tip elongation was noted.Another manufacturer's 0.014inch wire guide and microcatheter were used instead, which crossed the cto, and the procedure was completed successfully.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.According to the complainant, the complaint device will not be returned to the manufacturer for investigation.
Additional Manufacturer Narrative
Investigation ¿ evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.Additionally, an ifu is provided with the device, which states ¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be traced to the device but may lie with the patient¿s condition.We will continue monitor complaints for similar events and have notified the appropriate personnel of this event.Per the quality engineering 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.

• 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: 7893077
• Report Number: 1820334-2018-02772
• Device Sequence Number: 11354145
• Product Code: KRA
• UDI-Device Identifier: 00827002525450
• UDI-Public: (01)00827002525450(17)201128(10)8399976
• Combination Product (Y/N): N
• PMA/510(K) Number: K072724
• 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): 11/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: CXI-4.0-35-150-P-NS-DAV
• Device Lot Number: 8399976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1