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 2020-01-13 for SI AVANTI+ 6F STD W/GW NO OBT 504606X manufactured by Cordis Corporation.
[174925383]
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. It is unknown if the device will be returned for testing and evaluation.?? Additional information is pending and will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[174925384]
During a percutaneous coronary intervention case, a 6f vessel dilator broke and the broken part of the cannula stayed inside the body of the patient. The site was the femoral access. The device is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616099-2020-03473 |
| MDR Report Key | 9582602 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-05 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| 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 | SI AVANTI+ 6F STD W/GW NO OBT |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-01-13 |
| Model Number | 504606X |
| Catalog Number | 504606X |
| Lot Number | 17868525 |
| 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 60 AVENUE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |