MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for CROSSER CTO RECANALIZATION CATHETER CRUOS106 manufactured by Bard Peripheral Vascular, Inc..
[178748117]
As the lot number was provided, a lot history review will be performed. The return of the sample is pending. The company is still investigating the issue at this time.
Patient Sequence No: 1, Text Type: N, H10
[178748118]
This report summarizes one malfunction. A review of the reported information indicated that model cruos106, recanalization catheter, allegedly experienced an overheating issue. This information was received from a single source. This malfunction involved a (b)(6) year old female patient with no consequences. The patient's weight was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00300 |
| MDR Report Key | 9591783 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-15 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSSER CTO RECANALIZATION CATHETER |
| Generic Name | RECANALIZATION CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-15 |
| Model Number | CRUOS106 |
| Catalog Number | CRUOS106 |
| Lot Number | GFDT1757 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |