SOLOGRIP III HANDPIECE HP-SG3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-05-15 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..

Event Text Entries

[108290174] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10


[108290175] According to an email on 04/18/2018: presented to ed (emergency department) with "burning chest pain" with some nausea and vomiting over previous 2 days. Ecg (electrocardiogram) showed no st segment elevation. Started on a heparin and nitroglycerin drip which provided no relief of his chest pain. Cardiac catheterization on (b)(6) 2017 showed global hypokinesis with ef (ejection faction) 45 %, severe multi-vessel coronary artery disease, lima (left internal mammary artery) to lad (left anterior descending artery) has 50% proximal stenosis but fills the distal lad. Serial troponins were negative. Patient was discharged on (b)(6) 2017 to home. Was to follow up with cardiologist in one week to complete last of 35 total treatments of eecp (enhanced external counter pulsation).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1063481-2018-00013
MDR Report Key7514722
Report SourceSTUDY
Date Received2018-05-15
Date of Report2018-08-14
Date of Event2017-09-14
Date Facility Aware2018-04-18
Date Mfgr Received2018-04-18
Date Added to Maude2018-05-15
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 ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD, NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOLOGRIP III HANDPIECE
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Product CodeMNO
Date Received2018-05-15
Model NumberHP-SG3
Catalog NumberHP-SG3
Lot NumberTA 04093
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC.
Manufacturer Address1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2018-05-15

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