MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-25 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
[90284256]
The acist navvus catheter was discarded by the user facility and the lot number was not provided; therefore, device analysis and device history record (dhr) review could not be performed. Cineangiograms of the event were not provided by the user facility. A review of acist's complaint database was completed on (b)(6) 2017 to search for similar events across all navvus catheter lot numbers. This user facility report of distal emboli is the only reported event to acist in 99,220 navvus catheters sold since the catheter was released for distribution in 2014. Acist is unable to determine the cause of the event. This report is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[90284257]
The user facility reported that during an elective, outpatient diagnostic cath procedure using the acist rapid exchange ffr system, model rxi, with the navvus catheter, resistance was felt while advancing the catheter and plaque was displaced and moved distal in the vessel. The patient became hemodynamically unstable and required resuscitation. The patient became stable and the procedure was completed with another product. The exact date the case occurred was not reported and is unknown. The user reported that the lesion was very significantly blocked based on the ffr values obtained and rotoblator was performed. The patient left the lab stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134243-2017-00013 |
| MDR Report Key | 6978126 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-25 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-10-25 |
| 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 | JEFF AUDRITSH |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer G1 | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACIST |
| Generic Name | CATHETER, PRESSURE MONITORING, CARDIAC |
| Product Code | OBI |
| Date Received | 2017-10-25 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7905 FULLER ROAD EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-10-25 |