MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for AVANTI + 5F STD W/GW 504605X manufactured by Cordis Corporation.
[176112156]
A review of the manufacturing documentation associated with lot (17889752) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[176112157]
As reported, upon inspection of the sheath of a 5f avanti plus standard catheter sheath introducer (csi) with mini guidewire (gw) was found to have a small hole however, the tip was intact. Hemostasis was achieved by manual pressure. There was no reported patient injury. When the csi was removed, upon pulling back there was a blood clot on the arterial sheath. After the clot was pulled through which noted to have a fast oozing blood at the access sight in the right groin. On removal of arterial sheath at the right groin which noted to have a spraying of blood from mid-sheath and instantly ecchymosis was started at the target site, but no firm hematoma was felt. The sheath was tagged/bagged for further inspection. The product was stored as per labeling. The product was opened in the sterile field. The device was prepped according to the ifu. This was electrophysiology study case. The access site was the femoral vein. The device will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616099-2020-03467 |
| MDR Report Key | 9574605 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVANTI + 5F STD W/GW |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-01-10 |
| Model Number | 504605X |
| Catalog Number | 504605X |
| Lot Number | 17889752 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60TH AVE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |