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 ICESPHERE? 1.5 CX 90? CRYOABLATION NEEDLE FPRPR3573 manufactured by Galil Medical Ltd.
[186748425]
Two cryoablation needles were used to treat a sclerotic metastatic thoracic vertebral body using bipedicular access. After the procedure, a thermal lesion to the spinal cord was discovered. The patient is paraplegic as a result of the lesion. The user believes the thermal lesion to be related to the cryoablation procedure. There was no reported malfunction with the cryoablation needles, and the needles will not be returned to the manufacturer for investigation. An anonymised transverse image of the needle placement was sent by the user to the manufacturer to estimate the expected posterior limit of the iceball. This mdr is being submitted for the first needle used during this procedure. Please see mdr # 9616793-2020-00046 for the second needle used during this procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00045 |
| MDR Report Key | 9772515 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-29 |
| Date of Report | 2020-02-29 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-03-25 |
| 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 | ICESPHERE? 1.5 CX 90? CRYOABLATION NEEDLE |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-02-29 |
| Model Number | FPRPR3573 |
| Catalog Number | FPRPR3573 |
| Lot Number | A1974 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Life Threatening; 2. Required No Informationntervention | 2020-02-29 |