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..
[180120463]
The lot number for the malfunction was provided and a lot history review was performed. The sample was not returned to the manufacturer for inspection. Therefore, the investigation of the reported malfunction is inconclusive. Based upon the available information, the definitive root cause for this malfunction is unknown. The device is labeled for single use. (b)(4). The catalog number identified has not been cleared in the us, but is similar to the crosser cto recanalization catheters products that are cleared in the us. The pro code for the crosser cto recanalization catheters products is identified.
Patient Sequence No: 1, Text Type: N, H10
[180120464]
This report summarizes one malfunction. A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced fracture, material deformation, noise/audible, and material split, cut or torn. This information was received from one source. The event involved a patient with no known impact to the patient. The patient age, weight, and gender were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00254 |
| MDR Report Key | 9588848 |
| 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 | GFCY3312 |
| 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 |