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 2020-01-22 for 5F 10CM SW RADIAL 506510S manufactured by Cordis Corporation.
[176116545]
The exact lot number is unknown. It was reported the lot number involved is most likely lot 17860727 or 17870327. A review of the manufacturing documentation associated with lot 17860727 was performed and presented no issues during the manufacturing process that can be related to the reported complaint. Additional information is pending and will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[176116546]
As reported, the needle of a 5f 10cm stainless steel wire (sw) rain sheath introducer was felt blunt. The device was used as usual. The patient had little post-interventional bleeding as the artery was perforated. A pressure bandage was applied as a treatment/procedure provided to the patient as a result of the arterial perforation. The product look/appear normal when taken from its packaging. There was no any treatment provided to the patient as a result of the blood loss. The device was intact when removed from the patient. The device will not be returned for evaluation as it was discarded by the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616099-2020-03499 |
| MDR Report Key | 9616394 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-08 |
| Date of Event | 1980-01-01 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2019-05-07 |
| Date Added to Maude | 2020-01-22 |
| 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 | 5F 10CM SW RADIAL |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-01-22 |
| Model Number | 506510S |
| Catalog Number | 506510S |
| Lot Number | 17860727 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-22 |