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

Model Number	G18376
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D9, h3: one device was returned to cook.H3: device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.E3: occupation = manager of ct lab.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 or Problem Description
As reported, during a lower extremity angiogram with below-the-knee intervention, during which two cxi support catheters were used, the tip of another manufacturer¿s 0.014-inch, 300-centimeter wire guide separated and remains in the patient.Access was obtained in the femoral artery to target a vessel below the knee.The first catheter and wire were used; however, the wire reportedly stuck upon both advancement and withdraw of the wire through the catheter.Reportedly, upon removal of the wire from the catheter, ¿material came off¿ of the wire.Another cxi and another 0.014-inch, 300-centimeter wire were then used; however, the other manufacturer¿s wire also stuck upon advancement and withdraw through the catheter.The wire and catheter were removed together.The cxi catheters did not separate.The fragment of the other manufacturer¿s separated wire remains in the anterior tibial artery, as retrieval of the wire fragment was considered ¿too risky¿.Per the reporter, the patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Summary of event: as reported, during a lower extremity angiogram with below-the-knee intervention, during which two cxi support catheters were used, the tip of another manufacturer¿s 0.014-inch, 300-centimeter wire guide separated and remains in the patient.Access was obtained in the femoral artery to target a vessel below the knee.The first catheter and wire were used; however, the wire reportedly stuck upon both advancement and withdraw of the wire through the catheter.Reportedly, upon removal of the wire from the catheter, ¿material came off¿ of the wire.Another cxi and another 0.014-inch, 300-centimeter wire were then used; however, the other manufacturer¿s wire also stuck upon advancement and withdraw through the catheter.The wire and catheter were removed together.The cxi catheters did not separate.The fragment of the other manufacturer¿s separated wire remains in the anterior tibial artery, as retrieval of the wire fragment was considered ¿too risky¿.Per the reporter, the patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The tip was out of round.A sample wire was advanced through the catheter without difficulty.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on a sub-assembly lot; however, the affected product was scrapped prior to release from cook.A review of complaint history found one additional complaint for this lot number, received from the same facility as the complaint device.The product ifu states ¿to ensure hydrophilic activation, wet the entire surface of the catheter.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a sub-assembly lot, the non-conforming product was scrapped prior to release from cook, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that procedural issues related to interaction between the wire and cxi catheter 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
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN ; 8123392235
• MDR Report Key: 21305294
• Report Number: 1820334-2025-00115
• Device Sequence Number: 15496061
• Product Code: KRA
• UDI-Device Identifier: 00827002183766
• UDI-Public: (01)00827002183766(17)260524(10)15459199
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 05/24/2026
• Device Model Number: G18376
• Device Catalogue Number: CXI-2.3-14-150-ANG
• Device Lot Number: 15459199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC V14-300CM GUIDE WIRE
• Patient Sex: Unknown