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

Model Number	G51580
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 a large thrombus dvt and using a crosscath support catheter, the catheter tore/ripped.Access was gained through the right popliteal and advanced through the femoral.This occurred toward the middle of the procedure.The patient was noted to have big clots.The contrast did not go through the end hole, it went out through the side.It was injected by hand.The device was removed and there were no pieces missing.A 5fr glide catheter was used to complete the procedure.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a large thrombus dvt and using a crosscath support catheter, the catheter tore/ripped.Access was gained through the right popliteal and advanced through the femoral.This occurred toward the middle of the procedure.The patient was noted to have big clots.The contrast did not go through the end hole, it went out through the side.It was injected by hand.The device was removed and there were no pieces missing.A 5fr glide catheter was used to complete the procedure.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complainant returned cxc4.8-3.7-35-90-p-ns-0 (crosscath support catheter) to cook for investigation.Physical examination of the returned device showed: one used device was returned.The "ripped" section was noted at 1.5cm from the distal tip.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: ¿catheter manipulation should only occur under fluoroscopy.¿ ¿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 pr remove the obstruction.¿ ¿do not advance catheter without the wire extending out of the distal tip.¿ how supplied: ¿upon removal from packaging, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible patient anatomy contributed to the failure due to the noted big clots.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 or Problem Description
No new patient or event information to report.

• Brand Name: CROSSCATH SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11962068
• Report Number: 1820334-2021-01480
• Device Sequence Number: 11113331
• Product Code: KRA
• UDI-Device Identifier: 00827002515802
• UDI-Public: (01)00827002515802(17)230421(10)13144510
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K161801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 04/21/2023
• Device Model Number: G51580
• Device Catalogue Number: CXC4.8-3.7-35-90-P-NS-0
• Device Lot Number: 13144510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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: ADVANTAGE GLIDEWIRE