MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for VISIONS PV .035 DIGITAL IVUS CATHETER 88901 manufactured by Volcarica S.r.l..
[185222758]
Volcano catheter would not track over a benson. 035 wire. It was then tried to track over a glidewire, which failed to track over it as well. A new catheter was used and worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888417 |
| MDR Report Key | 9888417 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-24 |
| Report Date | 2020-02-06 |
| Date Reported to FDA | 2020-02-06 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONS PV .035 DIGITAL IVUS CATHETER |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-02-07 |
| Catalog Number | 88901 |
| Lot Number | 88901 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOLCARICA S.R.L. |
| Manufacturer Address | 9965 FEDERAL DR COLORADO SPRINGS CO 80920 US 80920 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |