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 Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

As reported, it was noted that approximately ¼ of the sealant was still at the end of the hypo tube, upon removal of the 5f mynxgrip vascular closure device (vcd).Hemostasis was achieved with the remaining ¾ of the sealant and manual compression for thirty minutes or less.There was no reported patient injury.The device storage temperature did not exceed 25 °c.The user was trained on the use of the mynx device.The intended procedure was a diagnostic peripheral.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was a femoral arterial and was 7mm in size.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site, however, there was little vessel tortuosity.The sheath used in conjunction with the mynx was a 5f.There was no excess force applied during insertion.The balloon was fully deflated after shuttling down.The patient was neither hospitalized nor was the patient's hospitalization extended as a result of the event.The patient is noted to have recovered.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot f1834401 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 limited information available for review, handling factors during device removal may have contributed to the sealant stuck to the advancer tube after removal.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, 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, part of the sealant could be dislodged, resulting in the reported incident.Neither the phr, 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, it was noted that approximately ¼ of the sealant was still at the end of the hypo tube, upon removal of the 5f mynxgrip vascular closure device (vcd).Hemostasis was achieved with the remaining ¾ of the sealant and manual compression for thirty minutes or less.There was no reported patient injury.The device storage temperature did not exceed 25 °c.The user was trained on the use of the mynx device.The intended procedure was a diagnostic peripheral.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was a femoral arterial and was 7mm in size.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site, however, there was little vessel tortuosity.The sheath used in conjunction with the mynx was a 5f.There was no excess force applied during insertion.The balloon was fully deflated after shuttling down.The patient was neither hospitalized nor was the patient's hospitalization extended as a result of the event.The patient is noted to have recovered.The device will not be returned for evaluation as it was not saved by the site.

• 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: 8378128
• MDR Text Key: 137423449
• Report Number: 3004939290-2019-01058
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)201231(10)F1834401
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MX5021
• Device Catalogue Number: MX5021
• Device Lot Number: F1834401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/28/2019
• Date Device Manufactured: 12/11/2018
• 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
• Treatment: UNKNOWN 5F SHEATH