MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-29 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.
[181482051]
Three needles were used during a renal cryoablation case. The patient was under conscious sedation during the procedure. A small muscle spasm was observed during the first freeze cycle of the cryoablation procedure. The user continued with the case as planned. A large muscle spasm was observed during the first active thaw cycle. The user stopped the procedure, and identified the faulty needles by turning active thaw on and off sequentially on each needle. The users identified that needles 1 and 3 were causing the muscle spasm. The user decided to only use active thaw on needle 2. During the last freeze cycle, a small spasm was observed again. The active thaw on needle 2 failed during the final active thaw cycle, so passive thaw was used on needle 2 as well. The case was completed with no reported injury to the patient. All 3 needles will be returned to the manufacturer for investigation. This mdr is to report the electrical malfunction for needle 3. Please see the following mdr's for the other needles used during this cryoablation procedure: mdr # 9616793-2020-00042 - needle 1; mdr # 9616793-2020-00043 - needle 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00044 |
| MDR Report Key | 9772485 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-29 |
| Date of Report | 2020-02-29 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-29 |
| 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 | 2020-02-29 |
| Model Number | FPRPR3602 |
| Catalog Number | FPRPR3602 |
| Lot Number | T0221 |
| 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 | 2020-02-29 |