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 2020-03-31 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd..
[186748543]
Four iceforce needles were used in a renal cryoablation procedure. During the procedure, the patient developed a hematoma that was not near the entry site of the needle. The physician believed that the hematoma formed because they used too many needles during the cryoablation procedure. The hematoma was successfully drained, and the patient was kept in hospital for a couple of days after the procedure for observation. No further injury was reported for the patient. The case was successfully completed. Frost developed along the shaft on one of the needles. This malfunction did not contribute to development of the hematoma. No other device malfunction was reported. This mdr is for the second needle used during this case. For the other needles, please refer to the following mdrs listed below: mdr # 9616793-2020-00070 - needle 1 - frost on the shaft. Mdr # 9616793-2020-00072 - needle 3 - no failure reported. Mdr # 9616793-2020-00073 - needle 4 - no failure reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616793-2020-00071 |
| MDR Report Key | 9907769 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-31 |
| 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 | ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE |
| Generic Name | CRYOABLATION NEEDLE |
| Product Code | GEH |
| Date Received | 2020-03-31 |
| Model Number | FPRPR3602 |
| Catalog Number | FPRPR3602 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |