Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDINAL HEALTH SANTA CLARA MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  malfunction  
Event Description
As reported, a 6f/7f mynxgrip vascular closure device (vcd) was defective and failed.The device did not deploy correctly.It just seemed to split when the user pushed it down and then up.It just seemed defective.There was no reported patient injury.The device will be returned for evaluation.
 
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 6f/7f mynxgrip vascular closure device (vcd) was defective and failed.The device did not deploy correctly.It just seemed to split when the user pushed it down and then up.It just seemed defective.There was no reported patient injury.The device will be returned for evaluation.Addendum: product evaluation demonstrates that it was noted that the sealant was exposed adhering to the catheter shaft.
 
Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
Complaint conclusion: as reported, a 6f/7f mynxgrip vascular closure device (vcd) was defective and failed.The device did not deploy correctly.It just seemed to split when the user pushed it down and then up.It just seemed defective.There was no reported patient injury.A non-sterile ¿mynxgrip vascular closure device 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that the shuttle was engaged to the black handle.The syringe was received connected to the device, and the stopcock was observed opened.The procedural sheath was not received for evaluation.The advancer tube was observed to have remained in the shuttle cartridge tubing as received.It was noted that the sealant was exposed adhering to the catheter shaft.In addition, the balloon was noted fully deflated.The device was inspected for damages that may have contributed to the reported event, and no visual damages or anomalies were observed.Dimensional analysis was performed to verify the advancer tube¿s length and distance between the proximal and distal tamp locks, and the measurements were noted to be within specification.Per functional analysis, a simulated deployment test was performed to ensure functionality of the returned device.The sealant was found adhered to the catheter shaft and it was removed.After removal, the shuttle was able to be advanced without issue, and the advancer tube was found properly engaged to the proximal tamp lock during the device failure investigation.The returned device performed as intended per the mynxgrip instructions for use (ifu).Per microscopic analysis, visual inspection at high magnification showed that the tamp locks were inspected for damages that may have prevented the advancer tube from engaging to the proximal tamp lock during the procedure, and no damages or anomalies were observed.In addition, it was noted that the sealant was exposed, adhering to the catheter shaft.The reported events of ¿sealant-failure to deploy¿ and ¿sealant-sealant stuck to device components¿ were confirmed through analysis of the returned device since the sealant was found adhered to the to the catheter shaft.The exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the limited information available for review, it is difficult to determine what factors may have contributed to the reported incident of the sealant failing to deploy/becoming stuck to the device, especially since there were no damages or anomalies noted to the device.However, procedural/handling factors are possible, such as incomplete engagement of the advancer tube or the sealant prematurely hydrating and adhering to the device components which created resistance and obstructed the device path during the procedure.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, ¿while pulling lightly on the device handle (to ensure the balloon is abutting the arteriotomy or venotomy), open the procedural sheath stopcock and confirm temporary hemostasis.Detach shuttle and advance in a continuous motion until a definitive stop is felt.Immediately grasp the procedural sheath and withdraw it from the tissue tract.Continue retracting until the shuttle locks on the handle.¿ it should be noted that if the shuttle is not advanced until the advancer tube is engaged to the proximal tamp lock (definitive stop), this will cause the advancer tube and sealant to follow the shuttle cartridge back out of the tissue tract during the retraction step, resulting in the device failing to deploy.Neither the product analysis, nor the information available for review, suggest that the reported failure experienced could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly:.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MYNXGRIP
Type of Device
DEVICE, HEMOSTASIS, VASCULAR
Manufacturer (Section D)
CARDINAL HEALTH SANTA CLARA
5452 betsy ross drive
santa clara CA 95054
Manufacturer (Section G)
CORDIS US CORP.
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
5452 betsy ross drive
santa clara, FL 95054
7863138372
MDR Report Key17919501
MDR Text Key325484362
Report Number3004939290-2023-03420
Device Sequence Number1
Product Code MGB
UDI-Device Identifier10862028000410
UDI-Public10862028000410
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberMX6721
Device Lot NumberF2316001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-