MAUDE Adverse Event Report: SC003 SC-FORT MILL CATH LAB TRAY (CCROI)156; GENERAL SURGERY TRAY (KIT)

Model Number	SAN12CCROJ
Health Effect - Clinical Code	Thrombus (2101)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the results received from the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.Device history record, lot# f93754 was manufactured between the 19th to 22nd of mar 2018.No exception was recorded in the device history record that could lead to the reported incident.Six pieces of samples were returned for investigation.The linting test result is 0.161g / 6 pieces.According to the manufacturer, the operating room towel is made of cotton, so lint is born and inevitable.The intended use of the or towel is used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.The manufacturer has worked with cardinal health to better control the linting and have implemented several measures to improve the linting in the towel.Based on the investigation, all linting test data is within the acceptable range.There is no abnormal situation that has happened in production.Therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no additional action taken at this time, but the manufacturer will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer stated that the blue operating room towels, component pwtb03-stma from catalog san12ccroj/cath lab tray, were unraveling causing free floating strings.The strings reportedly caused a thrombus in the patient¿s right coronary artery which was able to be removed by a pronto thrombus extraction catheter.Upon the follow up visit with the patient, residual thrombus was found and required covered stents to be placed to prevent further thrombus.The patient is now stable but with the additional stents, the patient will require long term anti-coagulation.The event date is unknown.

• Brand Name: CATH LAB TRAY (CCROI)156
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7973175
• Report Number: 1423537-2018-00242
• Device Sequence Number: 19225451
• Product Code: LRO
• UDI-Device Identifier: 10885425518159
• UDI-Public: 10885425518159
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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?: No
• Operator of Device: Other
• Device Model Number: SAN12CCROJ
• Device Catalogue Number: SAN12CCROJ
• Device Lot Number: 493240
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 10/17/2018
• 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