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 CATHETERS CRUS6A manufactured by Bard Peripheral Vascular, Inc..
[177379680]
The lot number was provided, therefore a lot history review was performed. The sample was returned for evaluation and fracture and torn material was confirmed. The investigation is unconfirmed for material twisted/bent. The definitive root cause is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[177379681]
This report summarizes one malfunction. A review of the reported information indicates that model crus6a recanalization catheter experienced a fracture, twisted material, and material split. The information was received from one source. The malfunction involved a patient with no reported patient injury. The male patient is (b)(6) years old and weighs (b)(6) pounds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00275 |
| MDR Report Key | 9591279 |
| 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 CATHETERS |
| Generic Name | RECANALIZATION CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-15 |
| Model Number | CRUS6A |
| Catalog Number | CRUS6A |
| Lot Number | GFDR1661 |
| 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 |