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 2020-02-27 for ICEROD 90 MRI NEEDLE / MRI SE FPRPR3195 manufactured by Galil Medical Ltd..
[182745229]
Needle 4 was returned to the manufacturer for investigation. The needle's atp and iceball formation properties were found within specification, and the reported complaint could not be confirmed from the needle investigation.
Patient Sequence No: 1, Text Type: N, H10
[182745230]
4 needles were used in a mri guided renal cryoablation procedure. During the case, all 4 icerod mri needles only reached an iceball size of approx. 1 cm, which was insufficient for the procedure. Extra active thawing cycles did not resolve this. Multiple freezing cycles were conducted in an attempt to reach an acceptable ablation zone. The treatment was deemed unsuccessful, and a new cryoablation procedure has been scheduled for this patient. All four needles were returned to the manufacturer for investigation, and the cryoablation system was investigated in a field service call. This mdr summarises the investigation results of the fourth needle used in this complaint. Please see the following mdr's for the other devices used during this cryoablation procedure: 3004462490-2020-00001 - cryoablation system, 9616793-2020-00035 - needle 1, 9616793-2020-00036 - needle 2, 9616793-2020-00037 - needle 3
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00038 |
| MDR Report Key | 9767066 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 90 MRI NEEDLE / MRI SE |
| Generic Name | CRYOSURGICAL DEVICES AND ACCESSORIES |
| Product Code | GEH |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-13 |
| Model Number | FPRPR3195 |
| Catalog Number | FPRPR3195 |
| 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 | 2020-02-27 |