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

Model Number MX6721

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

During integration of accessclosure, inc.Into the cordis business model, the determination was made that reportability for product failure modes would be aligned with current reportability for cordis products.This decision to align reportability was made, as the said failure modes, would not result in patient injury.As a result, this event is being filed beyond the 30-day fda requirement.(b)(6).(b)(4).Complaint conclusion: it was reported that a 6/f mynxgrip vascular closure device (vcd) could not cross through because of the tortuous vessel.There was no reported patient injury.The product is available for return.There were no damages or anomalies noted when removed from the package.The device prepped normally (i.E.Maintain negative pressure).The access site was located in the common femoral.The deployer was certified on mynx devices.The mynx (vcd) was prepped according to the instructions for use (ifu).The device was purged of air during the prep.There was no scar tissue present in the vicinity of the puncture site.A non-sterile mynxgrip vascular closure device 6f/7ff involved in the reported complaint was returned for investigation.Visual inspection of the returned device showed that the shuttle cartridge was disengaged from the handle.A 5f procedural sheath (off label use) was located on the polyimide shaft approximately 32 mm from the balloon proximal bond.The device¿s distal shaft was inspected for anomalies (i.E.Kinks, deformity that may have obstruct the device path during insertion).No anomalies were observed.A review of the manufacturing documentation associated with lot f1701302 presented no issues during the manufacturing process that can be related to the reported event.The failure reported as ¿could not cross through because of tortuous vessel¿ could not be confirmed due to the condition in which the unit was received for analysis.The tortuous vessel may have caused difficulty for the catheter tip to make the "turn" into the vessel.It was observed that the returned 6f/7f device was used with a 5f procedural sheath (off label use) during the procedure.The instructions for use (ifu) specifies that 5f or smaller sheaths must be exchanged to a 6f or 7f before inserting the mynx.Failure to follow the ifu by using a smaller than specified sheath size with a device may result in resistance during shuttling or a device jam.Neither the dhr review nor the product analysis suggests that the failure experienced by the customer is related to the mynx manufacturing process.Procedural factors and handling process may have contributed to the failure reported.No corrective or preventive actions will be taken at this time.Should additional relevant information become available, a supplemental mdr will be filed.

Event Description

It was reported that a 6/f mynxgrip vascular closure device (vcd) could not cross through because of tortuous vessel.There was no reported patient injury.The product is available for return.There were no damages or anomalies noted when removed from the package.The device prepped normally (i.E.Maintain negative pressure).The access site was located in the common femoral.The deployer was certified on mynx devices.The mynx (vcd) was prepped according to the instructions for use (ifu).  the device was purged of air during the prep.There was no scar tissue present in the vicinity of the puncture site.

• 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
• Manufacturer (Section G): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: librada contreras ; 5452 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 6906617
• MDR Text Key: 89514693
• Report Number: 3004939290-2017-00369
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1700402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Distributor Facility Aware Date: 06/08/2017
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1