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 2020-03-13 for CATHETER EXIMO ATHERECTOMY 1.5MM EXM40010000 manufactured by Eximo Medical Ltd..
[188541108]
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 Sequence No: 1, Text Type: N, H10
[188541109]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2020-10003 |
| MDR Report Key | 9829115 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Catalog Number | EXM40010000 |
| Lot Number | EX017AF13 |
| 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 | 2020-03-13 |