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

Model Number	G56553
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: cath lab manager.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, before an intervention of the sfa a cxi support catheter was being prepared when the tip of the catheter broke off.It is currently unknown how the procedure was completed.No portion of the device remained in the patient.The patient did not experience any adverse effects due to this occurrence.This did not result in the need for prolonged hospitalization or additional procedures.Additional information has been requested, but is not available at this time.
Event or Problem Description
Additional information was received on 29jul2020 stating that there was no packaging damage.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report.As reported, before an intervention of the sfa a cxi support catheter was being prepared when the tip of the catheter broke off.It is currently unknown how the procedure was completed.No portion of the device remained in the patient.The patient did not experience any adverse effects due to this occurrence.This did not result in the need for prolonged hospitalization or additional procedures.Additional information has been requested, but is not available at this time.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and dimensional verification as well as a visual inspection of the returned device were conducted during the investigation.One cxi catheter was returned.Biomatter was found on the hub, but no visible damage to the catheter.The catheter length was 151.2cm to the separation, and the black tip measures 4mm.All dimensions deemed relevant to the failure were analyzed and determined that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.One relevant non-conformance for tip/taper inadequate was discovered.However, all nonconforming product was scrapped and there is a 100% inspection for the reported nonconformance.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which states ¿remove the catheter spiral holder from its sealed packaging.¿ based on the information provided and the examination of the returned product, cook has concluded a component failure without a manufacturing or design deficiency contributed to this incident.If a lot of force was used to remove the catheter from the plastic tubing this could have caused the tip to separate.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• 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: 10321413
• Report Number: 1820334-2020-01359
• Device Sequence Number: 10929456
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)221113(10)10147607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 11/13/2022
• Device Model Number: G56553
• Device Catalogue Number: CXI-2.6-18-150-ANG
• Device Lot Number: 10147607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1