FDA.reportPublic FDA data

MAUDE MDR 9817256

MDR report key
9817256
Report number
9616793-2020-00060
Event key
0
Event type
3
Date of event
2020-02-11
Date received
2020-03-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SANDRA BAUSBACK-ABALLO
Address
300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR WEST CONSHOHOCKEN, PA US
Phone
331-331-3311
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ICEROD CX 90? NEEDLE/VLCRYOABLATION NEEDLEGALIL MEDICAL LTDGEHFPRPR3533FPRPR3533T0013Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1101. L

Event Narratives#

N

Patient 1

THE FOUR NEEDLES USED IN THIS CRYOABLATION PROCEDURE WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. ONE OUT OF THE FOUR NEEDLES (FROM LOT T0013) FAILED ELECTRICAL TESTING, WITH THE OTHER THREE NEEDLES ELECTRICAL PROPERTIES WITHIN SPECIFICATIONS. DISASSEMBLY OF THE DEFECTIVE NEEDLE REVEALED THE ROOT CAUSE OF THE EVENT AS DAMAGE OF THE INSULATION LAYER OF THE HEATER WIRE SUSTAINED DURING ASSEMBLY. THE NEEDLE LOT MANUFACTURING RECORDS FOR T0013 DID NOT SHOW ANY ELECTRICAL MALFUNCTIONS WITHIN THE NEEDLE BATCH.

D

Patient 1

FOUR CRYOABLATION NEEDLES WERE USED DURING A CRYOABLATION PROCEDURE. DURING THE ACTIVE THAW (ITHAW) CYCLE OF THE CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED AN ELECTRIC SHOCK. THE ITHAW FEATURE WAS TURNED OFF, AND PASSIVE THAW WAS USED TO CONTINUE WITH THE PROCEDURE. THE CASE WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. ALL FOUR CRYOABLATION NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.