MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-15 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
[5417919]
During a patient procedure to obtain an intravascular pressure measurement using the acist rapid exchange (rxi) system and navvus catheter, a dissection of a patient's left anterior descending (lad) artery occurred while advancing the navvus catheter under mild resistance over the bmw (balance middle weight) guidewire. The physician reported that the lesion was not hazy or unstable before the insertion of the navvus catheter. The location of the dissection was in the mid-portion of the artery where tortuosity was present but calcification was not. The patient remained stable. The guidewire remained in place until after a stent was placed. The navvus catheter is unavailable; it was discarded.
Patient Sequence No: 1, Text Type: D, B5
[12854006]
The acist navvus catheter was discharged by the user facility, therefore, no device evaluation could be performed. The lot number of the navvus catheter and a copy of the cine-angiogram of the patient case were requested from the user facility but were not provided to acist. From the information provided by the user facility, there was no indication of a malfunction, however, a dissection was reported during the patient procedure. The dissection was successfully treated by stenting the vessel. The patient remained stable and the patient was discharged from the hospital the following day. Due to the limited information obtained from the user facility and lack of the navvus catheter for evaluation, acist is unable to determine the cause of the event; the cause of the event is inconclusive. If additional information should become available, acist will submit a follow-up report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134243-2015-00001 |
| MDR Report Key | 4434233 |
| Report Source | 05,06 |
| Date Received | 2015-01-15 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-12-10 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KERRY VAN DER ROER |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522534574 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACIST |
| Generic Name | DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | OBI |
| Date Received | 2015-01-15 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-01-15 |