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

Model Number G52547

Device Problem Material Perforation (2205)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, a cxi support catheter was perforated by a wire guide during an unspecified procedure.The device was inserted into the patient and attempted to be advanced over the aortic bifurcation.The catheter then kinked at the point of the second marker band.Multiple attempts were made to cross the kink within the catheter using a wire guide to retrieve the device, during which one wire guide perforated the device.The kink was eventually able to crossed, and the device was successfully removed from the patient.Additional information regarding the event and patient outcome has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 was received 02sep2021.The access site was the right iliac artery.The patient's anatomy was not tortuous or calcified.The kink and perforated device happened at the end of the procedure.The patient's outcome was "okay.".

Event Description

No new patient or event information to report since the previous medwatch report was submitted.

Manufacturer Narrative

Summary of event: as reported, a cxi support catheter was perforated by a wire guide during an unspecified procedure.The device was inserted into the patient and attempted to be advanced over the aortic bifurcation.The catheter then kinked at the point of the second marker band.Multiple attempts were made to cross the kink within the catheter using a wire guide to retrieve the device, during which one wire guide perforated the device.The kink was eventually able to crossed, and the device was successfully removed from the patient.The access site was the right iliac artery.The patient's anatomy was not tortuous or calcified.The kink and perforated device happened at the end of the procedure.The patient's outcome was "okay." investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complainant returned one cxi support catheter to cook for investigation.Physical examination of the returned device revealed that a puncture on the body of the catheter was present at 5.2 cm for the distal tip.In response to this incident, cook reviewed the device history record (dhr).The dhr for the reported lot revealed no nonconformances.The subassembly records relevant nonconformances for shaft damage and bent/kinked, but all nonconforming products were scrapped, and the lot is inspected 100%.A database search for complaints related to the complaint lot reveals no other complaints reported at this time.Therefore, cook concludes that no nonconforming product exists in house or in the field.Cook also completed a document review.Cook reviewed the device master record (dmr) and product labeling to establish the manufacturing specifications, the operation parameters, and the design verification testing of the device.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also review reviewed the product labeling.The instructions for use (ifu) provides the following to the user related to the reported failure mode: how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook concluded that component failure was the primary cause of this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12405981
• MDR Text Key: 269348035
• Report Number: 1820334-2021-02092
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002525474
• UDI-Public: (01)00827002525474(17)240421(10)13906614
• Combination Product (y/n): N
• PMA/PMN Number: K160884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: G52547
• Device Catalogue Number: CXI-4.0-35-90-P-NS-DAV
• Device Lot Number: 13906614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 11/16/2021
• Supplement Dates FDA Received: 09/10/2021; 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO STANDARD WIRE