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

Model Number N/A

Device Problem Material Perforation (2205)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

As reported, during an unknown procedure, an unknown wire perforated an unspecified cxi support catheter.Additional information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: name and address: name: (b)(6).G4: pma/510(k) #: k160884 or k122796.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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

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 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.

Event Description

Additional information was received 28feb2024.The procedure was an aortogram with runoff via contralateral access in the common femoral artery to target the opposite leg.The anatomy was calcified.It is unknown what wire was used, if resistance was encountered, or at what point in the procedure the event occurred.It is unknown if the procedure was completed successfully, if any part of a device remained in the patient, if the patient required any additional procedures, or if the patient experienced any adverse effects due to the event.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, an unknown wire perforated an unspecified cxi support catheter.Additional information was received (b)(6) 2024.The procedure was an aortogram with runoff via contralateral access in the common femoral artery to target the opposite leg.The anatomy was calcified.It is unknown what wire was used, if resistance was encountered, or at what point in the procedure the event occurred.It is unknown if the procedure was completed successfully, if any part of a device remained in the patient, if the patient required any additional procedures, or if the patient experienced any adverse effects due to the event.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.The lot number was not provided to cook, and a global shipment search was unable to definitively determine the lot; therefore, the device history record and complaint history could not be reviewed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence that the user did not follow the instructions for use (ifu).The information provided upon review of the dmr and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to design or manufacturing, contributed to this event.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.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: 18580422
• MDR Text Key: 334775991
• Report Number: 1820334-2024-00122
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2024

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 04/11/2024
• Supplement Dates FDA Received: 03/06/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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