MAUDE Adverse Event Report: CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 5F; DEVICE, HEMOSTASIS, VASCULAR

Model Number MX5021

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f2102204 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.This is one of two products involved with the reported event and the associated manufacturer report number is 3004939290-2021-02248.

Event Description

As reported by the sales rep, the sealant of two (2) 5f mynxgrip vascular closure device (vcd) did not deploy and was stuck to the tube even after they removed the product.There was no reported patient injury.They felt the lot was bad hung on to device and threw the rest of the box out.The devices were stored as per labeling and opened in sterile field.The devices were not used in patient.The first device will be returned for analysis along with 2 other unused devices; the second device will not be returned for analysis.

Manufacturer Narrative

This report is related to report #3004939290-2021-02248.As reported by the sales rep, the sealant of two (2) 5f mynxgrip vascular closure device (vcd) did not deploy and was stuck to the tube even after they removed the product.There was no reported patient injury.They felt the lot was bad hung on to device and threw the rest of the box out.The devices were stored as per labeling and opened in sterile field.The devices were not used in patient.The first device will be returned for analysis along with 2 other unused devices; the second device will not be returned for analysis.(b)(4): the device was returned for analysis.One 5f mynxgrip non-sterile device was returned for investigation.Per visual analysis, the device was exposed to blood, the sealant was adhered to the shuttle tube, the shuttle was retracted to the handle, the procedural sheath was attached to the shuttle handle, and the syringe was attached to the device.The sealant was swollen.The advancer tube remained in the manufacturing position.Two unused/sterile 5f mynx grip devices, in the original packaging, from the same lot# f2102204, were also returned for investigation.Per functional analysis, the swollen sealant was removed from the catheter, and shuttle down procedure was simulated.The advancer tube was found to be engaged and shuttle was retracted back to the handle.The returned device performed as intended per mynxgrip ifu lbl9288_4.The two unused/sterile devices were prepped, the deployment test was performed and both devices performed as per the mynx grip instructions for use (ifu), lbl9288_4.Per microscopic analysis, the procedural sheath was removed from the catheter and inspected for any damages that could have affected the sealant to adhere to it, however, no anomaly was observed.The catheter when observed under high magnification and showed that the grip tip of the sealant and the sealant were protruding away from the catheter, and the sealant was swollen.No damages or anomalies were observed that could have obstructed the deployment.Per dimensional analysis, the distance between the proximal and distal tamp locks were measured and noted to be within specification.A product history review of lot f2102204, revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.(b)(4): the product was not returned for analysis.A product history record (phr) review of lot f2102204 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¿ was confirmed during analysis of the one returned device, as the sealant was adhered to the shuttle tube, however a functional analysis determined that the device functioned as intended.The exact cause of the difficulty experienced by the customer could not be conclusively determined.The reported issue could not be confirmed on the second device as it was not returned for evaluation.Procedural factors may have contributed to the cause of this event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, 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, the sealant could be dislodged from the vessel wall, resulting in the reported incident.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 actions will be taken at this time.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 5F
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 12193434
• MDR Text Key: 262678317
• Report Number: 3004939290-2021-02249
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)230131(10)F2102204
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: MX5021
• Device Catalogue Number: MX5021
• Device Lot Number: F2102204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 125