FDA.reportPublic FDA data

MAUDE MDR 9907773

MDR report key
9907773
Report number
9616793-2020-00073
Event key
0
Event type
3
Date of event
2020-02-28
Date received
2020-03-31
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
1ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLECRYOABLATION NEEDLEGALIL MEDICAL LTD.GEHFPRPR3602FPRPR3602R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

FOUR ICEFORCE NEEDLES WERE USED IN A RENAL CRYOABLATION PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA THAT WAS NOT NEAR THE ENTRY SITE OF THE NEEDLE. THE PHYSICIAN BELIEVED THAT THE HEMATOMA FORMED BECAUSE THEY USED TOO MANY NEEDLES DURING THE CRYOABLATION PROCEDURE. THE HEMATOMA WAS SUCCESSFULLY DRAINED, AND THE PATIENT WAS KEPT IN HOSPITAL FOR A COUPLE OF DAYS AFTER THE PROCEDURE FOR OBSERVATION. NO FURTHER INJURY WAS REPORTED FOR THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED. FROST DEVELOPED ALONG THE SHAFT ON ONE OF THE NEEDLES. THIS MALFUNCTION DID NOT CONTRIBUTE TO DEVELOPMENT OF THE HEMATOMA. NO OTHER DEVICE MALFUNCTION WAS REPORTED. THIS MDR IS FOR THE FOURTH NEEDLE USED DURING THIS CASE. FOR THE OTHER NEEDLES, PLEASE REFER TO THE FOLLOWING MDRS LISTED BELOW: MDR # 9616793-2020-00070 - NEEDLE 1 - FROST ON THE SHAFT. MDR # 9616793-2020-00071 - NEEDLE 2 - NO FAILURE REPORTED. MDR # 9616793-2020-00073 - NEEDLE 3 - NO FAILURE REPORTED