PRELUDE IDEAL HYDROPHILIC INTRODUCER SHEATH 10884450317379 PID6F11018NTPD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-25 for PRELUDE IDEAL HYDROPHILIC INTRODUCER SHEATH 10884450317379 PID6F11018NTPD manufactured by Merit Medical Systems Inc..

Event Text Entries

[186549383] The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[186549384] The account alleges that during percutaneous transluminal assess for a medical procedure, the hub of the introducer detached when the clinician was attempting to remove the access guidewire and the introducer. No patient injury to report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721504-2020-00021
MDR Report Key9881121
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-25
Date of Report2020-02-27
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2020-02-27
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVID LOCKRIDGE
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN, UT
Manufacturer CountryUS
Manufacturer Phone2531600
Manufacturer G1MERIT MEDICAL SYSTEMS INC.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN, UT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRELUDE IDEAL HYDROPHILIC INTRODUCER SHEATH
Generic NameINTRODUCER SHEATH
Product CodeDYB
Date Received2020-03-25
Returned To Mfg2020-03-02
Model Number10884450317379
Catalog NumberPID6F11018NTPD
Lot NumberH1740235
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS INC.
Manufacturer Address1600 MERIT PARKWAY SOUTH JORDAN, UT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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