| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CATHETER EXIMO ATHERECTOMY 1.5MM | PERIPHERAL ATHERECTOMY CATHETER | EXIMO MEDICAL LTD. | MCW | EXM40010000 | EX017AF13 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-13 | 0 | 1. R |
Patient 1
THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. 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 1
AS DR. DAS ATTEMPTED TO USE THE 1.5 ATHERECTOMY DEVICE AT 50 MJ, THERE WAS A WARNING "SENSORY ERROR" WITHIN 3-4 SECONDS TWICE IN A ROW BEFORE THE DEVICE WOULD FUNCTION PROPERLY. ONCE THE DEVICE BEGAN TO FUNCTION, THE FIRST RUN DOWN THE SFA @50MJ WAS EXTREMELY TIGHT (THROUGHOUT) AND DR. DAS FELT TENSION. THE CATHETER WOULD NOT PASS THROUGH THE DISTAL SFA CAP AND I {ANGIODYNAMICS REPRESENTATIVE} ADVISED HIM TO RUN THE CATHETER IN THE CAP FOR 10 SECONDS (@50MJ) AND THEN ATTEMPT TO PASS THROUGH BUT AGAIN IT WOULD NOT CROSS THE LESION. DR. DAS THEN SAID HE WANTED TO TREAT THE LESION AT 60MJ, I ADVISED HIM THAT THE ENGINEERS AND IFU DO NOT RECOMMEND THIS FOR THE ENTIRE LENGTH OF A LESION, BUT BECAUSE HE HAD SIGNIFICANT TENSION THROUGHOUT THE PROCEDURE HE FELT THAT THIS WAS ESSENTIAL FOR A POSITIVE OUTCOME. THE CATHETER ADVANCED FINE UNTIL IT AGAIN REACHED THE DISTAL CAP AND WOULD NOT ADVANCE. I AGAIN SUGGESTED FOR ALLOWING THE DEVICE TO RUN FOR 10 SECONDS ON THE LESION (AND TO CONSIDER A BALLOON INFLATION IF IT DID NOT SUCCEED). DR DAS RAN AT 60MJ FOR 10 SECONDS ON THE CAP THEN ATTEMPTED TO CROSS AGAIN BUT THE CATHETER WOULD NOT ADVANCE. WHEN DR. DAS BEGAN TO REMOVE THE CATHETER FROM THIS LESION THE BLADE DETACHED AND APPEARED TO BE STUCK IN THAT LESION (STILL ON THE WIRE). HE WAS ULTIMATELY ABLE TO RETRIEVE THE BLADE WITH A SMALL BALLOON AND PULL IT OUT OF THE SHEATH. HE WAS ABLE TO SUCCESSFULLY COMPLETE THE INTERVENTION WITH POSITIVE RESULTS AND NO HARM TO THE PATIENT. THE DEVICE WAS INDICATED AS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.