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 2020-02-17 for EMBOSHIELD NAV 6 22438-19 manufactured by Abbott Vascular.
[179718987]
(b)(4). The device was received. 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
[179718988]
It was reported that during preparation of the emboshield nav6 embolic protection system, the filtration element failed to load into the delivery catheter and the support structure of the filtration element became deformed (bent) and the pod wrinkled. The torque device was not used. There was no patient involvement. A new emboshield nav6 was used to successfully continue the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Device analysis identified the filtration element support structure to be broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01530 |
| MDR Report Key | 9717412 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-02-17 |
| 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 | 2020-02-17 |
| Returned To Mfg | 2020-01-06 |
| Model Number | 22438-19 |
| Catalog Number | 22438-19 |
| Lot Number | 9080861 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-17 |