HERCULES III T401161 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-12 for HERCULES III T401161 N/A manufactured by Terumo Cardiovascular Systems Corporation.

Event Text Entries

[113868311] Terumo has received the device for evaluation; however, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4). Results: results pending completion of evaluation. Conclusions: conclusion not yet available-evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10


[113868312] The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, an abrasion was discovered on the heart. Per user facility the distal end/ lip of the unit was sharp/ abrasive and it rubbed and created an abrasion on the heart. There was a delay for less than a minute; product was changed out; procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1124841-2018-00138
MDR Report Key7683321
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-07-12
Date of Report2018-09-21
Date of Event2018-06-05
Date Mfgr Received2018-09-21
Date Added to Maude2018-07-12
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 ContactMS. CATHLEEN HARGREAVES
Manufacturer Street125 BLUE BALL ROAD
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002837866
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameHERCULES III
Generic NameUNIVERSAL STABILIZER ARM
Product CodeDTZ
Date Received2018-07-12
Returned To Mfg2018-07-03
Model NumberT401161
Catalog NumberN/A
Lot NumberT00255
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address125 BLUE BALL ROAD ELKTON MD 21921 US 21921

Device Sequence Number: 1

Brand NameHERCULES III
Generic NameUNIVERSAL STABILIZER ARM
Product CodeMSW
Date Received2018-07-12
Returned To Mfg2018-07-03
Model NumberT401161
Catalog NumberN/A
Lot NumberT00255
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address125 BLUE BALL ROAD ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-12

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