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 2020-02-12 for EMBOSHIELD NAV 6 22438-19 manufactured by Abbott Vascular.
[180336210]
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[180336211]
It was reported that the procedure was performed to treat a heavily calcified distal right superficial femoral artery. During retrieval of the emboshield nav6 embolic protection system, the filter got stuck in the artery due to a large calcium deposit. A clinically significant delay was reported as a cut down surgery was performed to manually remove the filter. There was no adverse patient sequela reported. No additional information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01418 |
| MDR Report Key | 9701086 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2020-02-12 |
| 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. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSHIELD NAV 6 |
| Generic Name | EMBOLIC PROTECTION SYSTEM |
| Product Code | NTE |
| Date Received | 2020-02-12 |
| Model Number | 22438-19 |
| Catalog Number | 22438-19 |
| Lot Number | 9102961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |