FDA.reportPublic FDA data

MAUDE MDR 6608050

MDR report key
6608050
Report number
1063481-2017-00019
Event key
0
Event type
3
Date of event
2017-04-28
Date received
2017-06-02
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
ROCHELLE MANEY
Address
1655 ROBERTS BLVD KENNESAW GA 30144 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOLOGRIP III HANDPIECESYSTEM LASER TRANSMYOCARDIALCRYOLIFE, INC.MNOHP-SG3HP-SG3TA-04097R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-020

Event Narratives#

N

Patient 1

A REVIEW OF THE OUTSIDE OF THE HANDPIECE WAS PERFORMED. VISIBLE BURN MARKS WERE OBSERVED AT THE PROXIMAL END OF THE SHEATH (WHITE PORTION OF THE HANDPIECE). IT WAS ALSO NOTED THAT A WHITE RING COULD BE SEEN WITHIN THE BURN MARKS SUGGESTING A BREAK AND/OR BEND AT THAT POINT. THE HANDPIECE WAS ATTACHED TO THE LASER FOR TESTING. THE LASER LIGHT DID NOT TRAVEL TO THE END OF THE SHEATH. THE SHEATH WAS REMOVED FROM THE HEAT SHRINK (BLACK PORTION) AND NOTICEABLE BURN MARKS AT THE END OF THE SHEATH WERE OBSERVED. THE LASER LIGHT COULD BE VIEWED AT THE END OF THE KNURLED NUT BUT DUE TO DAMAGE TO THE SHEATH, THE LIGHT DID NOT TRAVEL FURTHER. THE HEAT SHEATH WAS OPENED SO THE INSIDE COULD BE VIEWED. BASED ON ALL OBSERVED DAMAGE TO THE HANDPIECE IT WAS SUGGESTED THAT THE CAUSE OF THE BURNING WAS DUE TO A BEND OR BREAK IN THE SHEATH OVER THE SINGLE FIBER. A DEFINITIVE ROOT CAUSE IS UNKNOWN AND THE INVESTIGATION IS CURRENTLY ONGOING. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

D

Patient 1

INITIAL REPORTS FOR THE EVENT STATED THAT THE HANDPIECE WAS TESTED AND FIRED ONCE WITH NO PROBLEMS. THE DEVICE WAS THEN FIRED A SECOND TIME AND A "POP" WAS HEARD. A BURNING SMELL WAS NOTICED AND A CHARRED AREA WAS VISIBLE (EXACT LOCATION NOT SPECIFIED). THE RESULTANT DELAY IN THE PROCEDURE DID NOT CAUSE ADVERSE IMPACT TO THE PATIENT. THE PATIENT WAS DISCHARGED HOME AFTER THE PROCEDURE.