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U.S. Department of Health and Human Services

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

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CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR Back to Search Results
Model Number N/A
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
Udi # is (b)(4). The device was not returned for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt. The device is available but was not yet returned for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt. This is one of 5 devices associated with the reported event but the manufacturing report numbers are not available. The related numbers are 3004939290-2019-01041 and 3004939290-2019-01042, 3004939290-2019-01043, 3004939290-2019-01044.
 
Event Description
The 6f-7f mynxgrip balloon did not feel as if it fully deflated after deployment and the user felt resistance upon pulling it out. Hemostasis took longer than expected to achieve. There was no patient injury and the device will be returned for analysis. This is one of 5 events from the same facility involving the same lot number. The users were trained and were very experienced operators at this lab. All had the same complaint. The device was opened in a sterile filed and were used in the patient. The product was also stored according to the labeling. Additional details were requested but were not available.
 
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Brand NameMYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F
Type of DeviceDEVICE, 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 Key8351559
MDR Text Key136593188
Report Number3004939290-2019-01045
Device Sequence Number1
Product Code MDB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/26/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberN/A
Device Catalogue NumberMX6721
Device Lot NumberF1831202
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1
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