MAUDE Adverse Event Report: CORDIS SANTA CLARA UNKNOWN MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number UNK-MYNXGRIP

Device Problems Separation Failure (2547); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

As reported, the user felt resistance while completely shuttling down the 5f mynxgrip vascular closure device (vcd) in a 5f non-cordis sheath.When the mynx and sheath were retracted back, the shuttle tube was not in place.The sealant was attached on the wire.There was no reported patient injury.The user is trained on the use of the mynx device.No other information was available.The product was not returned for analysis as it was not saved by the site.A lot history review was not possible as the lot number was not provided.However, product release at cardinal health is contingent upon the successful completion of lot release testing, including sterilization prior to shipment and a documentation review by the quality department.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product instructions for use, users are instructed that 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.Blood within the device may cause the sealant to swell which will cause resistance as the user shuttles down.Without a lot number to conduct a product history record review, it is not possible to determine if the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the user felt resistance while completely shuttling down the 5f mynxgrip vascular closure device (vcd) in a 5f non-cordis sheath.When the mynx and sheath were retracted back, the shuttle tube was not in place.The sealant was attached on the wire.There was no reported patient injury.The user is trained on the use of the mynx device.

• Brand Name: UNKNOWN MYNXGRIP
• 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: 8510182
• MDR Text Key: 141797970
• Report Number: 3004939290-2019-01149
• Device Sequence Number: 1
• Product Code: MGB
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-MYNXGRIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• 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