MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER

Catalog Number PTWS-2FLL-MLL-R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a transcatheter arterial chemoembolization (tace) procedure, a three-way plastic stopcock leaked.The leak occurred while mixing lipiodol and an unspecified chemotherapy drug.The device was replaced with another to complete the procedure.The patient did not require any additional procedures or interventions due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Summary of event: as reported, during a transcatheter arterial chemoembolization (tace) procedure, a three-way plastic stopcock leaked.The leak occurred while mixing lipiodol and an unspecified chemotherapy drug.The device was replaced with another to complete the procedure.The patient did not require any additional procedures or interventions due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, and documentation was conducted during the investigation.As the device was not returned; a device failure analysis was not performed.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.There is no evidence to suggest that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Based on the information provided and the results of the investigation, cook has concluded that the stopcock stems molded of nylon 6 have the potential to absorb moisture, resulting in an increase in diameter, raising the potential for cracking of the stopcock body.The risk assessment for this failure mode was reviewed, and no additional escalation actions are recommended or 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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9720343
• MDR Text Key: 194503717
• Report Number: 1820334-2020-00386
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)230907(10)9147818
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 9147818
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/11/2020
• Patient Sequence Number: 1