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

Model Number	N/A
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address - phone: (b)(6).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
As reported, during an endovascular treatment procedure, another manufacturer's 0.014-inch wire guide perforated a cxi support catheter.Access was obtained in the right common femoral artery and an ipsilateral approach was used to target a chronic total occlusion within the superficial femoral artery (sfa).The other manufacturer's wire guide was inserted into the complaint device and during use, the wire perforated the middle of the catheter, reportedly coming out of the device.Another manufacturer's device was used to complete the procedure.Although the lesion in the sfa was totally occluded, calcification was not reported.The anatomy was not tortuous.Resistance was not reported as the wire guide was advanced into the catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during an endovascular treatment procedure, another manufacturer's 0.014-inch wire guide perforated a cxi support catheter.Access was obtained in the right common femoral artery and an ipsilateral approach was used to target a chronic total occlusion within the superficial femoral artery (sfa).The other manufacturer's wire guide was inserted into the complaint device and during use, the wire perforated the middle of the catheter, reportedly coming out of the device.Another manufacturer's device was used to complete the procedure.Although the lesion in the sfa was totally occluded, calcification was not reported.The anatomy was not tortuous.Resistance was not reported as the wire guide was advanced into the catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for evaluation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file provides evidence to support that the device was manufactured to specification.There is no evidence to suggest that nonconforming product exists in house or in field.The product ifu 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." cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this complaint could not be determined.Possible causes include interaction with the wire device, patient anatomy or procedural factors.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.
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: 11100565
• Report Number: 1820334-2020-02396
• Device Sequence Number: 11784384
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)230221(10)13001367
• Combination Product (Y/N): N
• PMA/510(K) Number: K160884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 13001367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 25CM MEDIKIT/PARENT/6F ACCESS SHEATH; ASAHI INTEC 0.014INCH ASTATO XS9-40; 25CM MEDIKIT/PARENT/6F ACCESS SHEATH; ASAHI INTEC 0.014INCH ASTATO XS9-40