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 2020-03-11 for ICEPEARL 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3601 manufactured by Galil Medical Ltd.
[183175724]
During the freeze cycle in a renal cryoablation procedure, one icepearl collected frost on the needle shaft. The patient's skin was protected to continue with the case. The case was completed with no injury to the patient. The reported defective needle will be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00062 |
| MDR Report Key | 9817317 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-11 |
| 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 | ICEPEARL 2.1 CX 90? CRYOABLATION NEEDLE |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-03-11 |
| Model Number | FPRPR3601 |
| Catalog Number | FPRPR3601 |
| 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 YOKNEAM, 2069203 IS 2069203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |