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 2020-02-13 for EMBOSHIELD NAV 6 22443-19 manufactured by Abbott Vascular.
[179280657]
Visual, dimensional and functional analysis performed on returned device. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The investigation was unable to determine a conclusive cause for the reported difficulty to insert. It may be possible that the filter was pulled into the pod too quickly. Additionally, it may be possible that the difficulty was related to the loading tray; however, without having the tray to examine, this could not be confirmed. Although there is no indication of a product quality issue with respect to manufacture, design or labeling for the returned components, an investigation will be conducted regarding recent incidents of difficulty to insert (load) the emboshield nav6 device. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
Patient Sequence No: 1, Text Type: N, H10
[179280658]
It was reported that during preparation of an emboshield nav6 embolic protection system (eps) the filter could not be inserted into the delivery catheter pod. The delivery catheter pod was wrinkled. The eps was not used and there was no patient involvement. 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 returned device analysis identified a vertical tear in the filter membrane proximal to the filter support structure assembly for a length of 1. 5mm. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01457 |
| MDR Report Key | 9706445 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2020-02-13 |
| 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 | 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 | 2020-02-13 |
| Returned To Mfg | 2019-12-18 |
| Catalog Number | 22443-19 |
| Lot Number | 8082961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-13 |