MAUDE Adverse Event Report: COOK INC TRIFORCE¿ PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number	G56413
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: administrative assistant.Pma/510(k) number: k170931.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an angioplasty procedure of the subclavian vein, a cook triforce peripheral crossing set leaked at the sideport.Access was obtained in the right cubital vein and the device was advanced into the subclavian vein as a two unit set.The physician then attempted to aspirate and flush the sheath while the catheter was inside; however, was unable to flush the device.The physician then removed the catheter and blood was reportedly seeping through the sideport of the sheath.The device was removed and replaced with a new device to complete the procedure.The patient's anatomy was not reported to be tortuous or calcified, no resistance was reported during the procedure, and the device was not used with a power injector.Ultimately, the procedure was not successful in creating a lumen between the subclavian vein and the superior vena cava; although, this was reported to be unrelated to the issue with the complaint device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection and a functional test of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one kcxs-5.0-35-65-rb-0/dav-hc was returned to cook for investigation.Hemostats were used to occlude the sheath tip to perform a leak test using a 20cc syringe with water.The device leaked form the side port.Upon further inspection, the side port was noted to be cracked on the underside.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.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.An ifu is also provided with this device, which notes ¿flush the flexor sheath through its side arm with heparinized saline solution or sterile water.¿ as well as upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event 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: TRIFORCE¿ PERIPHERAL CROSSING SET
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9167946
• Report Number: 1820334-2019-02554
• Device Sequence Number: 2774374
• Product Code: KRA
• UDI-Device Identifier: 00827002564138
• UDI-Public: (01)00827002564138(17)220722(10)9810949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 07/22/2022
• Device Model Number: G56413
• Device Catalogue Number: KCXS-5.0-35-65-RB-0/DAV-HC
• Device Lot Number: 9810949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR