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

Catalog Number CXI-4.0-35-135-P-NS-0

Device Problem Material Separation (1562)

Patient Problems Aneurysm (1708); No Code Available (3191)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: en snare® retrieval snare (merit), advantage glide wire (terumo) no code available ((b)(4)) for adverse event/ intervention.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported an (b)(6) male patient with unknown past medical history was undergoing a lower extremity angioplasty procedure.Access was gained via the brachial artery.While attempting to advance the cxi support catheter over the tortuous bifurcation, resistance was felt making it impossible to advance further.It was additionally reported, the physician was twisting the complaint cxi support catheter and using a bit of force, shoving the device.The device buckled and was difficult to remove over a 0.35 inch glide wire.Upon removal of the complaint device from the patient's anatomy, it was noted approximately 15 cm had detached in the patient.A snare was used to remove the separated portion from the brachial artery access.The angioplasty procedure was aborted and rescheduled but cancelled because the patient was seen in the emergency department with aneurysmal complications in the brachial artery.Although requested, no information has been provided regarding the patient outcome or if the original procedure was rescheduled.

Manufacturer Narrative

Additional information: additional information was received from the customer.The customer confirmed that the device was originally placed in the right brachial artery when the difficult advancement was noticed.Additionally, it was confirmed that the device separated when the removal was attempted.The physician then reportedly gained access via the left brachial artery to successfully snare the broken piece.However, the patient later returned complaining of pain and swelling in their left thigh.The physician believed that the patient needed some type of "repair," and referred the patient to another facility as they did not perform the type of procedure that the physician believed the patient needed.The patient's outcome is uncertain at this time; the only information available was that, after the second procedure, the patient returned again to the second facility complaining of "bleeding problems." no further information was provided by the customer at this time.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter was separated into two segments at the 3rd marker band from the distal tip.No notable damage was observed along the shaft until the point of separation, at which point twisting damage was noted.Additionally, a kink was noted near the distal tip, and the tip was compressed.This compression impeded a smooth advancement of wire through both ends.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 one nonconforming event which could contribute to this failure mode; however, the device was scrapped and not replaced.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, the root cause cannot be traced to the device; additionally, the patient¿s anatomy was tortuous, which could have been a factor which contributed to the failure mode.We will continue to monitor for similar complaints.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 Description

Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7931332
• MDR Text Key: 122620365
• Report Number: 1820334-2018-02587
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002525429
• UDI-Public: (01)00827002525429(17)200726(10)8093749
• Combination Product (y/n): N
• PMA/PMN Number: K072724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: CXI-4.0-35-135-P-NS-0
• Device Lot Number: 8093749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR