MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for CROSSER CTO RECANALIZATION CATHETERS CRE14S manufactured by Bard Peripheral Vascular, Inc..
[178248006]
The catalog number identified has not been cleared in the us, but is similar to the crosser cto recanalization catheter products that are cleared in the us. The product code for the crosser cto recanalization catheter product is identified. For the reported malfunction, a lot number was provided, and a lot history review was performed. The sample was returned to the manufacturer for evaluation. After further evaluation, ,material separation was identified on the device. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[178248007]
This report summarizes one (1) malfunction. A review of the reported malfunction indicated that model cre14s cto recanalization catheters experienced material separation and failure to advance. This report was received from one source. This malfunction involved a patient with no patient consequences. Age, weight, and gender was not provided for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00255 |
| MDR Report Key | 9588851 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| Catalog Number | CRE14S |
| Lot Number | GFCV0269 |
| 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 | 2020-01-14 |