MAUDE Adverse Event Report: CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F; DEVICE, HEMOSTASIS, VASCULAR

Model Number	MX6721
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported by the sales rep, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) popped while prepping the device.There was no reported patient injury.The product was stored as per labeling.The staff in the room did not save the devices or the packaging.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿balloon loss of pressure at prep¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.According to the instructions for use (ifu), which is not intended as a mitigation of risk, users are instructed to discard devices that do not maintain balloon pressure.As no lot number, catalogue code or other product information was supplied a phr could not be completed.The information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported by the sales rep, the balloon of a 6f-7f mynxgrip vascular closure device (vcd) popped while prepping the device.There was no reported patient injury.The product was stored as per labeling.The staff in the room did not save the devices or the packaging.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
As reported by the sales rep, the balloon of a 6f-7f mynxgrip vascular closure device (vcd) popped while prepping the device.There was no reported patient injury.The product was stored as per labeling.The product was returned for analysis.A non-sterile mynxgrip vascular closure device 6f/7f involved in the reported complaint was returned for investigation.Per visual analysis, the shuttle cartridge was engaged to the black handle, the syringe was connected to the device with the stopcock open, and the sealant and advancer tube were observed to have remained in the manufacturing position as received.The procedural sheath was not returned with the device.Per functional analysis, leak testing was performed on the balloon of the returned device and found no leak in the balloon.Pressure was maintained with proper functioning of the inflation indicator per the mynxgrip instructions for use.A product history record (phr) review of lot f2009203 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon loss of pressure at prep¿ was not confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.Handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, users are instructed to discard devices that do not maintain balloon pressure.Neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 10387967
• Report Number: 3004939290-2020-01844
• Device Sequence Number: 19379712
• Product Code: MGB
• UDI-Device Identifier: M465MX67210
• UDI-Public: M465MX67210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: MX6721
• Device Catalogue Number: MX6721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/11/2020
• Patient Sequence Number: 1