MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for CROSSER CTO RECANALIZATION CATHETERS CRUS6A manufactured by Bard Peripheral Vascular, Inc..
[177969960]
The lot number was provided for both malfunctions and lot history reviews were done. The device has been returned for evaluation for one of the two malfunctions; the evaluation identified detachment. The device has not been returned for the second malfunction; the investigation is inconclusive for detachment as no objective evidence has been provided to confirm any alleged deficiency with the device. Based upon the available information, the definitive root cause is unknown. The devices are labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[177969961]
This report summarizes two malfunctions. A review of the reported information indicated that model crus6a recanalization catheter allegedly experienced a detachment. This information was received from various sources. Both malfunctions involved patients with no reported consequences. One patient was reported as a (b)(6)-year-old male; all other patient details were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00190 |
| MDR Report Key | 9582066 |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | CRUS6A |
| Catalog Number | CRUS6A |
| Lot Number | GFDP3807 |
| 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 | 2020-01-13 |