MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.
[183174830]
Two cryoablation needles were used in a renal cryoablation case. Both needles passed testing, with no failures detected. Within a few minutes of the first freeze, both needles began to frost on the needle shaft. In order to prevent the frost from reaching the patients skin, the physician filled a sterile glove with saline and a hot pack and placed it on the patient's skin for protection. The first thaw cycle of the procedure was passive, and the second thaw cycle of the procedure was active thaw (ithaw). During active thaw, the patient immediately started having muscle twitches. The ithaw was turned on and off each needle to isolate the needle causing the muscle spasm. Passive thaw was used for the defective needle, and active thaw was used for the other needle. The post-procedural scan of the patient looked normal, and the case was completed with no reported injury to the patient. Both needles will be returned to the manufacturer for investigation. This mdr is being submitted for the first needle where only the frost formation on the needle shaft was observed. Please see mdr # 9616793-2020-00048 for the needle that had both frost formation on the needle shaft and electrical stimulation malfunctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00047 |
| MDR Report Key | 9772207 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR |
| Manufacturer City | WEST CONSHOHOCKEN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| Manufacturer G1 | GALIL MEDICAL LTD. |
| Manufacturer Street | 1 TAVOR BUILDING PO BOX 224, INDUSTRIAL PARK |
| Manufacturer City | YOKNEAM, 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-02-28 |
| Model Number | FPRPR3602 |
| Catalog Number | FPRPR3602 |
| Lot Number | T0148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GALIL MEDICAL LTD |
| Manufacturer Address | 1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203 IS 2069203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |