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 2020-03-04 for CATHETER EXIMO ATHERECTOMY 1.5MM EXM40010000 manufactured by Eximo Medical Ltd..
[182336219]
The reported defective device has yet to be returned to the manufacturer for a device evaluation. The firm is attempting to obtain the device. An investigation into the root cause for product problem is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. Reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182336221]
A patient of unknown age and gender presented for an atherectomy procedure using the eximo system. A 1. 5 mm catheter was inserted through a 6 fr sheath into a bifurcation with kissing stent, lesions were located down the artery after the stent's location. Two lesions were ablated. The upper one, 1 cm long and the lower one, 3 cm long. These two lesions were treated by the same 1. 5mm catheter within less than 5 minutes at 50 and 60 mj/mm2. Once the catheter was removed from the body, it was found that the blade/catheter tip was not attached to it. The blade/catheter tip was removed from the treated area using a balloon partially inflated. The device was set aside and a new of the same device was used to perform a second treatment. It was indicated the device is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2020-10001 |
| MDR Report Key | 9785453 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-04 |
| 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 | DR. YOSSI MUNCHER |
| Manufacturer Street | 3 PEKERIS STREET SCIENCE PARK |
| Manufacturer City | REHOVOT, 7670203 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7670203 |
| Manufacturer G1 | EXIMO MEDICAL LTD. |
| Manufacturer Street | 3 PEKERIS STREET |
| Manufacturer City | REHOVOT, 7670203 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7670203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER EXIMO ATHERECTOMY 1.5MM |
| Generic Name | PERIPHERAL ATHERECTOMY CATHETER |
| Product Code | MCW |
| Date Received | 2020-03-04 |
| Catalog Number | EXM40010000 |
| Lot Number | EX017AF16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXIMO MEDICAL LTD. |
| Manufacturer Address | 3 PEKERIS STREET REHOVOT, 7670203 IS 7670203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |