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

Catalog Number	CXI-2.6-18-90-P-NS-ANG
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported a (b)(6) female underwent an unknown procedure during which the cxi support catheter was used.The distal tip of the device broke off inside of the patient.The physician could not retrieve the tip fragment; therefore, it remains in the patient's anatomy.Additional information regarding event details and patient outcome have been requested but not yet received.
Additional Manufacturer Narrative
The cook representative confirmed on 01/18/2019 that no additional information about this case will be provided by the physician.Additionally, an hhs/fda sus report ,reference mw5083171, was received 11 feb 2019 and states, "tip of catheter broke off.Patent was stented and piece was contained within the stent.No harm came to the patient".This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used cxi-2.6-18-90-p-ns-ang support catheter was returned for investigation.The distal tip was separated 80cm in from the strain relief at the 2nd marker band.A kink was noted 74.4cm and 78.1cm from the strain relief.No damage was noted under the strain relief.During the functional test a.018 wire guide when entered through the hub would not advance past the point of separation due to bio matter occluding the hub.Once the bio matter was removed the wire passed through without issue.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.However, while reviewing the subassembly lot two nonconformances were noted for gaps in lamination and foreign matter.While one of these is related to the reported failure mode, the affect units were scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device which 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." based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.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.
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: 8260822
• Report Number: 1820334-2019-00034
• Device Sequence Number: 159186
• Product Code: KRA
• UDI-Device Identifier: 00827002500020
• UDI-Public: (01)00827002500020(17)211017(10)9238890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072724
• 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,Followup
• Report Date (Section B): 03/13/2019

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: 10/17/2021
• Device Catalogue Number: CXI-2.6-18-90-P-NS-ANG
• Device Lot Number: 9238890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/18/2019; 03/12/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/11/2019; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR