MAUDE Adverse Event Report: Cordis US Corp MYNXGRIP; Device, Hemostasis, Vascular

Catalog Number	MX6721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: MYNXGRIP
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US Corp; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50873867
• Report Number: 3004939290-2026-01337
• Device Sequence Number: 10716184
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: Health Professional
• Device Catalogue Number: MX6721
• Device Lot Number: F2603303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 158 LB
• Patient Race: White