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

Model Number MX5021

Device Problems Migration or Expulsion of Device (1395); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

As reported, the sealant of the 5f mynxgrip vascular closure device (vcd) was shuttled down and the sheath pulled back, upon removal of the mynxgrip vcd, the sealant is sticking to the mynxgrip sheath and dislodging from the artery.There was no reported patient injury.The physician is a certified mynxgrip vcd user.The mynx vcd was prepped according to instructions for use (ifu).The device was storage temperature exceeded 25 °c.The sealant got stuck to the catheter.The entire sealant was stuck to the device component.The balloon was fully deflated after shuttling down.There was no over tamping as a 6f was used after with no issue.The balloon was fully deflated.The balloon was prepped with 100% saline.The balloon was not inverted.The device did not separate inside the patient.A 6f mynx vcd was used to achieve hemostasis.The patient's hospitalization was not extended as a result of the event.The device was not returned for analysis.A device history record (dhr) review of lot f1828201 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 information available for review, storage temperature factors (exceeded 25 °c) may have contributed to the sealant apposing to the sheath since temperatures above 25 °c can cause the sealant to soften and stick to the sheath/mynx device.According to the instruction for use, which is not intended as a mitigation, ¿maximum temperature, 25°c.Keep dry ¿ protect from moisture.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.¿ neither the dhr, 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.

Event Description

As reported, the sealant of the 5f mynxgrip vascular closure device (vcd) was shuttled down and the sheath pulled back, upon removal of the mynxgrip vcd, the sealant is sticking to the mynxgrip sheath and dislodging from the artery.There was no reported patient injury.The device will not be returned for evaluation.The physician is a certified mynxgrip vcd user.The mynx vcd was prepped according to instructions for use (ifu).The device was storage temperature exceeded 25 °c.The sealant got stuck to the catheter.The entire sealant was stuck to the device component.The balloon was fully deflated after shuttling down.There was no over tamping as a 6f was used after with no issue.The balloon was fully deflated.The balloon was prepped with 100% saline.The balloon was not inverted.The device did not separate inside the patient.A 6f mynx vcd was used to achieve hemostasis.The patient's hospitalization was not extended as a result of the event.The device will not be returned for evaluation.

• 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
• Manufacturer (Section G): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 8239259
• MDR Text Key: 132784692
• Report Number: 3004939290-2019-00947
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)201031(10)F1828201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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: MX5021
• Device Catalogue Number: MX5021
• Device Lot Number: F1828201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• 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