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

Model Number MX6721

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f1732604 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.

Event Description

As reported, the sealant of a 6f-7f mynxgrip vascular closure device (vcd) seemed to be stuck inside.There was no reported patient injury.

Manufacturer Narrative

As reported, the sealant of a 6f-7f mynxgrip vascular closure device (vcd) seemed to be stuck inside.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.A non-sterile 6f-7f mynxgrip vcd involved in the reported complaint was returned for investigation.Visual inspection of the returned device showed that the shuttle cartridge was engaged to the handle.The sealant and sealant sleeve remained in its manufactured position which likely indicates device was never inserted into a procedural sheath (sealant was not deployed).The catheter, shuttle cartridge and the advancer tube were inspected for damages that may have contributed to the reported event.No visual damages or anomalies were observed.Shuttle down procedure simulated (per mynxgrip instructions for use (ifu)) and the advancer tube was properly engaged to the tamp lock as intended.A device history record (dhr) review of lot f1732604 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 through analysis of the returned device.However, the condition of the returned device did not match the description of the incident since the sealant sleeve was still in its manufactured position.The exact cause of the reported failure experienced by the customer could not be conclusively determined.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue reported since the condition of returned device indicates that the device was never inserted into a procedural sheath.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, step 2: deploy sealant, it instructs users to align the balloon catheter with the tissue tract.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.Additionally, step 3: 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, and the sealant could be dislodged from the vessel wall, resulting in the reported incident.Neither the dhr, nor the product analysis or 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.

Manufacturer Narrative

As reported, the sealant of a 6f-7f mynxgrip vascular closure device (vcd) seemed to be stuck inside.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.The product was not returned for analysis.A product history record (phr) review of lot f1732604 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, it is not possible to determine what factors may have contributed to the issue reported.However, handling factors are possible.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, step 3: 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.

• 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
• MDR Report Key: 8473205
• MDR Text Key: 140619091
• Report Number: 3004939290-2019-01132
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)191130(10)F1732604
• Combination Product (y/n): N
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: MX6721
• Device Catalogue Number: MX6721
• Device Lot Number: F1732604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1