MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-30 for EMBOSHIELD NAV 6 22443-19 manufactured by Abbott Vascular.
[185726524]
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional emboshield device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[185726525]
It was reported that an emboshield nav6 embolic protection system (eps) was opened and it was noted that the deliver catheter (dc) pod was wrinkled and the filter could not be inserted into the dc pod. The eps was not used. A second emboshield nav6 eps was being prepared; however, the filter could not be inserted into the dc pod. The eps was not used. The procedure was successfully completed with a new emboshield nav6 eps. There were no adverse patient effects and no clinically significant delay in the procedure. The return device analysis identified that both eps's showed signs of use. The eps's were returned with blood on the coils and contrast on the dc pods, shafts, and coils. The return device analysis for the first eps identified that the proximal coil was separated (not in two separate pieces) 11. 5mm, 12mm and 5. 5cm distal to the proximal solder; however, the core was still intact. The return device analysis for the second eps identified that the dc pod was separated approximately 2. 5mm distal to the marker. There was a tear on the distal separated portion of the dc pod for a length of 3. 5mm. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03088 |
| MDR Report Key | 9898113 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-10-14 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-03 |
| Catalog Number | 22443-19 |
| Lot Number | 9041161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-30 |