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 CRE14S manufactured by Bard Peripheral Vascular, Inc..
[179313791]
The lot number was provided for the one malfunction; therefore, a lot history review is currently being performed. The sample was returned to bd for evaluation. 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 pro code for the crosser cto recanalization catheter product is identified. The sample was confirmed for the malfunction material separation and activation problem. Based upon the available information, the definitive root cause for this malfunction is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[179313792]
This report summarizes one malfunction. A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced material separation and activation problem. This information was received from one source. This malfunction did not involve the patient. There was no provided patient information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00319 |
| MDR Report Key | 9592295 |
| 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 |
| Catalog Number | CRE14S |
| Lot Number | GFCY3359 |
| 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 |