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 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot#: f2000702 presented no issues during the manufacturing process that can be related to the reported complaint.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

After shuttling down the sealant of a 5f mynxgrip vascular closure device (vcd), the unknown sheath was removed and noticed that the sealant was attached to the distal end of the sheath.Therefore, the balloon was removed, and manual compression was held.There was no reported patient injury.The doctor was trained with mynxgrip vcd.The product was stored as per labeling and prepped according to the instruction for use (ifu).The device will be returned for evaluation.

Manufacturer Narrative

After shuttling down the sealant of a 6f/7f mynxgrip vascular closure device (vcd), the unknown sheath was removed and noticed that the sealant was attached to the distal end of the sheath.Therefore, the balloon was removed, and manual compression was held.There was no reported patient injury.The doctor was trained with mynxgrip vcd.The product was stored as per labeling and prepped according to the instruction for use (ifu).The device was returned for analysis.A 6f/7f mynx grip vascular closure device was returned for evaluation.Per visual analysis, the shuttle was engaged to the handle, the sealant sleeve was displaced towards the handle, the procedural sheath was on the catheter, and the advancer tube was sent separately.It was reported that the sealant was noticed to be attached to the distal end of the sheath, however the sealant was not returned.Per functional analysis, since the condition of the returned device indicates complete removal, the shuttle was engaged, the advancer tube was out, and the sealant was not returned, a functional test could not be performed.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 sealant was not found on the returned procedure sheath or the catheter.A product history review of lot f2100801, 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 not confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.Procedural factors may have contributed to the reported 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: 11998472
• MDR Text Key: 259711599
• Report Number: 3004939290-2021-02198
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)220131(10)F2000702
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: MX5021
• Device Catalogue Number: MX5021
• Device Lot Number: F2000702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHEATH
• Patient Age: 54 YR
• Patient Weight: 145