MAUDE Adverse Event Report: SC003 SC-FORT MILL VA INVASIVE RADIOLOGY (IRPRB)503; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN30IRPRC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.No sample was returned for investigation.According to supplier, operating room towel is made of cotton, so lint is born and inevitable.The intended use of operating room towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface.Supplier had worked with cardinal to better control the linting and have implemented several measures to improve it: suction machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(b)(4), in the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production and all linting test data were within the acceptable range.Therefore, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported the blue towel pwtb03-stma from the invasive radiology pack san30irprc was used to wipe down the guidewire and a lot of lint was sticking to the guidewire during an angiography.A delay of 5 minutes was reported to replace the towels.There was no patient injury.

• Brand Name: VA INVASIVE RADIOLOGY (IRPRB)503
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 11957583
• Report Number: 1423537-2021-00638
• Device Sequence Number: 11093207
• Product Code: OEQ
• UDI-Device Identifier: 10887488972428
• UDI-Public: 10887488972428
• Combination Product (Y/N): N
• 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): 06/08/2021

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 Model Number: SAN30IRPRC
• Device Catalogue Number: SAN30IRPRC
• Device Lot Number: 582816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/08/2021
• 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