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 2020-03-08 for ICEROD CX 90? NEEDLE/VL FPRPR3533 manufactured by Galil Medical Ltd.
[182560233]
Two icerod cx 90 needles were used in a renal cryoablation procedure. The cryoablation system and needles both passed testing with no issues. The patient experienced muscle twitching during the first freeze cycle. The user moved the needles to different channels and identified the needle a7116-025 as the needle causing the twitching. A new needle was used to continue with the procedure, and performed as expected with no issues. The case was completed with no injury reported for the patient. The defective needle was discarded and will not be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00056 |
| MDR Report Key | 9803844 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-08 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-08 |
| 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 | ICEROD CX 90? NEEDLE/VL |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-03-08 |
| Model Number | FPRPR3533 |
| Catalog Number | FPRPR3533 |
| Lot Number | A7116 |
| 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 | 2020-03-08 |