MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE DESERT SPRING HEART 1 AND 2 PK(OHDSC)839; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV73OHDSC
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record could not be reviewed as a lot number was not provided.There are 18 occurrences reported in the past 12 months.According to the supplier, there is an inspection standard for linting issue.The number of loose threads falling off is less than three (=3) when shaking each piece of gauze.For this product, there is no linting issued found during their production process after they checked all the records for the past 12 months.As there is no lot number information and sample was not provided for investigation, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported fraying of the x-ray gauze c-nxr4416a from the heart pack scv73ohdsc.The surgeon stated that the fraying of lint was so bad that he is concerned that it should be documented as a retained foreign body and now they are removing from all kits prior to a procedure.No patient demographics or any clinical data was provided upon request.

• Brand Name: DESERT SPRING HEART 1 AND 2 PK(OHDSC)839
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 10590183
• Report Number: 1423537-2020-00530
• Device Sequence Number: 19429602
• Product Code: OEZ
• UDI-Device Identifier: 00885425802176
• UDI-Public: 00885425802176
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: SCV73OHDSC
• Device Catalogue Number: SCV73OHDSC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• 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