MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC RADIAL PACK (CRMPH)639; GENERAL SURGERY TRAY (KIT)

Model Number	SANW1CRMPI
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 190815794sh was reviewed, no exception was recorded in the device history record that could lead to the reported incident.According to the supplier, they have proper control in linting inspection.The sampling plan is general inspection level ll, acceptable quality limit: 0.015.At the time of the investigation no sample was available for evaluation.Only photos of the defect were provided, however, photos were unclear.Supplier was unable to confirm the defects based on the photos without the physical sample.No action will be taken at this time; however, we will continue to monitor the trend of this type of incident.
Event or Problem Description
Based on information received from the customer, allegedly lint from towel was found on wire during a percutaneous coronary international procedure (coronary stent).The customer reported there was no injury to the patient.The patient did fine and went home.

• Brand Name: CARDIAC RADIAL PACK (CRMPH)639
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 9632345
• Report Number: 1423537-2020-00399
• Device Sequence Number: 14175784
• Product Code: LRO
• UDI-Device Identifier: 10888439649734
• UDI-Public: 10888439649734
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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 Model Number: SANW1CRMPI
• Device Catalogue Number: SANW1CRMPI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Weight: 65