MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-05 for COOLTOUCH NS 160-15W manufactured by Syneron Medical Ltd..
[141099721]
A supplemental mdr will be submitted upon completion of the investigation by the plant.
Patient Sequence No: 1, Text Type: N, H10
[141099722]
Clinic reported to technical support that a (b)(6) year old female presented for endovenous ablation for incompetent right great saphenous vein (gsv). The incompetent vein was mapped and marked with ultrasound. Access was obtained above the level of the knee. Approximately 19 cm of the vein had been successfully treated, laser was set to 1 mm/second automatic withdrawal and the laser tip was clearly visualized within the vein. The guiding light became visible at the access point and what appeared to be the laser tip popped outside the skin. Inspection of the laser tip revealed the laser fiber had fractured inside the patient and an estimated 9-10 cm of glass fiber remained within the patient's saphenous vein. Patient was sent to an interventional radiologist who performed an ultrasound and then a phlebectomy of the remaining gsv on (b)(6) 2019. While removing the vein, the laser fiber popped outside the vein into the vascular space and could not be accessed through the incision, so patient was closed and fiber left within saphenous compartment. Subsequently, the patient saw a vascular surgeon and had a ct scan on (b)(6) 2019, localizing the fiber within the vein. The patient was scheduled for operative procedure on (b)(6) 2019 to have the remaining laser fiber removed by vascular surgeon. It was reported by the clinic that the patient is expected to heal and that scarring will be likely. Additional information solicited.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003772750-2019-00003 |
| MDR Report Key | 8488751 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2019-04-05 |
| 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 | YVERRE BOBAY |
| Manufacturer Street | 530 BOSTON POST RD |
| Manufacturer City | WAYLAND MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal | 01778 |
| Manufacturer Phone | 5083587400 |
| Manufacturer G1 | CANDELA CORPORATION |
| Manufacturer Street | 530 BOSTON POST RD |
| Manufacturer City | WAYLAND MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01778 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOLTOUCH |
| Generic Name | ND: YAG SURGICAL LASER |
| Product Code | PDZ |
| Date Received | 2019-04-05 |
| Model Number | NS 160-15W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON MEDICAL LTD. |
| Manufacturer Address | P.O. BOX 550 INDUSTRIAL ZONE YOKNEAM, ILLIT HA ZAFON 206920 IS 206920 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-04-05 |