MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-19 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
[73222673]
The acist navvus catheter was discarded by the user facility; therefore, no device evaluation could be performed. Cine-angiograms of the event were provided by the user facility and were evaluated by the acist medical advisory board (mab) on march 30, 2017. Review of the cine-angiograms confirmed the reported event; however, there were no images taken after the navvus catheter pressure measurements were taken and prior to the balloon inflation. The navvus catheter lot number was provided by the user and a device history record (dhr) review was performed by the supplier on april 11, 2017. The dhr review found that no component or device non-conformances were noted that would have a causal relationship to the reported event for navvus catheter lot ml00002950. A query of acist's complaint database was completed on april 17, 2017. There are no reports of potential patient injuries associated with navvus catheter lot ml00002950. There was no evidence of device malfunction based on the review of the cine-angiograms of the patient procedure, navvus catheter dhr for lot ml00002950, or acist complaint database. Acist is unable to determine the cause of the event. This report is considered closed. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[73222674]
The user facility reported that during a case using the acist rxi and navvus catheter, lot ml00002950, a dissection occurred. The first ffr pressure measurements were completed on the mid-right coronary artery without incidence, with ffr measurements of 0. 82 and 0. 86 with iv adenosine. The physician moved to the lesion on the distal left coronary artery which did not appear occluded on imaging. The navvus was advanced around the first bend of the lesion and resistance was observed. The navvus was unable to advance past the lesion. Pressure measurements were taken and ffr was observed at 0. 78 with iv adenosine. There was drift from equalization (ffr 1. 04), so additional measurements were taken, resulting in ffr values at 0. 79, 0. 78, and 0. 77 with no drift from equalization. No angiographic images were taken and the physician decided to balloon. Resistance was felt advancing the balloon past the same point where the navvus observed resistance. The balloon was inflated partially through the lesion. Contrast was injected to visualize the artery and a dissection of the lad was evident. Three drug eluting stents were placed to repair the artery. The physician successfully opened the vessel and the patient was stable. The patient was kept for observation and discharged the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134243-2017-00004 |
| MDR Report Key | 6505020 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-19 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-24 |
| Device Manufacturer Date | 2015-04-28 |
| Date Added to Maude | 2017-04-19 |
| 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 Phone | 9522534574 |
| 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 | 2017-04-19 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Lot Number | ML00002950 |
| Device Expiration Date | 2017-04-28 |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-04-19 |