MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PACEMAKER PACK BRO (PMABA)656; CARDIOVASCULAR PROCEDURE KIT

Model Number	SANCGPMAB3
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.According to supplier, the operations process is in strict compliance with the standard operation procedure (sop) of gauze swab production.No sample was returned for investigation, therefore supplier was unable to determine the root cause and to confirm the complaint description.Supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
It was reported that during a cardiac procedure there was shredding from gauze, c-nxr4416a, from pacemaker pack, sancgpmab3.There was no patient injury.The shred was seen next to an open pocket and was removed with adson forceps.It did not cause any delays.No further clinical data or patient demographics were provided after numerous attempts to obtain.

• Brand Name: PACEMAKER PACK BRO (PMABA)656
• 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: 11903060
• Report Number: 1423537-2021-00637
• Device Sequence Number: 17029833
• Product Code: OEZ
• UDI-Device Identifier: 10195594062958
• UDI-Public: 10195594062958
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: SANCGPMAB3
• Device Catalogue Number: SANCGPMAB3
• Device Lot Number: 611328
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/28/2021
• 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