DLP PERICARDIAL/INTRACARDIAC SUMPS 12112

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-12-19 for DLP PERICARDIAL/INTRACARDIAC SUMPS 12112 manufactured by Medtronic Perfusion Systems.

Event Text Entries

[5200793] Medtronic received information indicating that during the use of this cannula, the cannula perforated the back of the patient? S heart. A second pump run was required to resolve the event. The surgeon was using this cannula as a substitute due to the unavailability of the surgeon? S normal cannula. The surgeon stated that this cannula was more rigid, which resulted in the perforation. The cannula was discarded by the customer and will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[12671548] The device was discarded by the customer and will not be returned to medtronic for evaluation. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[101847883] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2184009-2014-00097
MDR Report Key4346786
Report Source05,07,COMPANY REPRESENTATIVE,
Date Received2014-12-19
Date of Report2014-11-21
Date of Event2014-11-21
Date Mfgr Received2014-11-21
Date Added to Maude2014-12-19
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC STRUCTURAL HEART
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDLP PERICARDIAL/INTRACARDIAC SUMPS
Generic NameSUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
Product CodeDTS
Date Received2014-12-19
Model Number12112
Catalog Number12112
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PERFUSION SYSTEMS
Manufacturer Address7611 NORTHLAND DRIVE MINNEAPOLIS MN 55428 US 55428


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2014-12-19

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