FDA.reportPublic FDA data

MAUDE MDR 3632922

MDR report key
3632922
Report number
2184009-2014-00009
Event key
0
Event type
3
Date received
2014-02-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MIKE GAFFNEY
Address
8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DLP CARDIAC SUCTION TUBESUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASSPERFUSION SYSTEMSDTS10052100522013081725N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-1801. R

Event Narratives#

D

Patient 1

MEDTRONIC RECEIVED INFORMATION SUGGESTING THAT DURING THE USE OF THIS CANNULA, THE BLUE SOFT TIP END OF THE CANNULA DETACHED FROM THE CANNULA AND WAS LOOSE IN THE PATIENT. THE TIP WAS FOUND IN THE PATIENT'S HEART. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE EVENT OR THE PATIENT'S CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION SUGGESTING THAT DURING THE USE OF THIS DLP SUCTION TUBE, THE BLUE SOFT TIP END OF THE TUBE DETACHED FROM THE TUBE AND BECAME LOST IN THE PATIENT. THE TIP WAS FOUND IN THE PATIENT'S HEART.

N

Patient 1

MEDTRONIC RECEIVED INFORMATION THAT AT LEAST TWO MONTHS HAD ELAPSED BETWEEN THE DATE OF THE PRODUCT EVENT AND THE DATE THE USER FACILITY MADE MEDTRONIC AWARE OF THE PRODUCT EVENT. MEDTRONIC WAS INFORMED THAT DURING THIS TIME THE INDIVIDUALS INVOLVED WITH THIS PRODUCT EVENT BECAME UNAFFILIATED WITH THE FACILITY. THE FACILITY WAS UNABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT OR PRODUCT EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ANALYSIS: MEDTRONIC HAS NOT RECEIVED THE PRODUCT ASSOCIATED WITH THIS PRODUCT EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. CONCLUSION: FOLLOWING THE PRODUCT EVENT INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

N

Patient 1

MEDTRONIC QUALITY ENGINEERS COULD NOT DETERMINE A CAUSE FOR THE PRODUCT EVENT BECAUSE THE DEVICE WAS NOT AVAILABLE FOR RETURN TO MEDTRONIC. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMALITIES WERE DOCUMENTED DURING THE MANUFACTURE OF THIS PRODUCT AND ALL INSPECTIONS PASSED. IF ANY FURTHER INFORMATION IS PROVIDED OR IF THE PRODUCT IS RETURNED TO MEDTRONIC THE EVENT WILL BE RE-EVALUATED AND A SUPPLEMENTAL REPORT WILL BE FILED.

N

Patient 1

CORRECTION WAS MADE TO THE EVENT DESCRIPTION TO SHOW THAT THE PRODUCT INVOLVED WAS A SUCTION TUBE RATHER THAN A CANNULA PRODUCT. NO OTHER CHANGES WERE MADE.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.