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.
[183175399]
The needle was returned to the manufacturer for investigation. The needle was found to be bent near the handle. The shaft temperature was found to be below specifications. Ice formed along the entire sleeve, confirming the reported complaint. Disassembly of the needle revealed that the vacuum sleeve had collapsed along the entire needle shaft. No soldering gaps, soldering flux or corrosive signs were visible on the sleeve's external surfaces. Multiple possible root causes were identified that could have caused the malfunction: vacuum sleeve thermal insulation loss, bending of the shaft or vacuum sleeve collapse onto the needle. The needle lot manufacturing records were reviewed, and no related deviations were found within the needle batch.
Patient Sequence No: 1, Text Type: N, H10
[183175400]
Two needles were used in a renal cryoablation procedure. During the freeze cycle, one of the needle's collected frost on the needle shaft. The patient's skin was protected by the user to continue the case and prevent injury. The iceball size was satisfactory for the user. The case was completed with no reported injury to the patient. The reported defective needle was returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00059 |
| MDR Report Key | 9817123 |
| 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 | 2019-07-10 |
| 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 | A6961 |
| 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 YOKNEAM, 2069203 IS 2069203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |