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

Model Number MX6721

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f1827602 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sealant of a 6f-7f mynxgrip vascular closure device (vcd) seemed to be stuck inside of the device.There was no reported patient injury.

Manufacturer Narrative

As reported, the sealant of a 6f-7f mynxgrip vascular closure device (vcd) seemed to be stuck inside of the device.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.The product was not returned for analysis.A product history record (phr) review of lot f1827602 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿sealant stuck to device components¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue reported could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue reported.However, handling factors are possible.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, step 3: remove device, it instructs users to ensure complete balloon deflation, then slowly withdraw the balloon catheter through the advancer tube lumen.Failure to hold the advancer tube in place and/or a proper position of the tamping tube was not maintained during catheter removal, part of the sealant could be dislodged, resulting in the reported incident.Neither the phr, nor the information available for review suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 8478011
• MDR Text Key: 140922554
• Report Number: 3004939290-2019-01135
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)201031(10)F1827602
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1827602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1