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 ICEROD CX 90? NEEDLE/VL FPRPR3533 manufactured by Galil Medical Ltd.
[183175280]
The four needles used in this cryoablation procedure were returned to the manufacturer for investigation. One out of the four needles (from lot t0013) failed electrical testing, with the other three needles electrical properties within specifications. Disassembly of the defective needle revealed the root cause of the event as damage of the insulation layer of the heater wire sustained during assembly. The needle lot manufacturing records for t0013 did not show any electrical malfunctions within the needle batch.
Patient Sequence No: 1, Text Type: N, H10
[183175281]
Four cryoablation needles were used during a cryoablation procedure. During the active thaw (ithaw) cycle of the cryoablation procedure, the patient experienced an electric shock. The ithaw feature was turned off, and passive thaw was used to continue with the procedure. The case was completed with no reported injury to the patient. All four cryoablation needles were returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00060 |
| MDR Report Key | 9817256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-08-12 |
| 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 | ICEROD CX 90? NEEDLE/VL |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-02-23 |
| Model Number | FPRPR3533 |
| Catalog Number | FPRPR3533 |
| Lot Number | T0013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-11 |