MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for ACIST CVI 014657 manufactured by Acist Medical Systems, Inc..
[176947745]
Acist has requested that the acist angiographic injection system, model cvi, serial number (b)(4), be sent to acist or investigation. Upon completion of the investigation, acist will submit a follow-up report to fda.
Patient Sequence No: 1, Text Type: N, H10
[176947746]
After injecting into the left ventricle during a left ventricle catheterization procedure, the physician rinsed the high pressure tubing with saline to perform pressure measurements in the left ventricle and noted bubbles in the high pressure tubing. The patient experienced a transient ischemic attack (tia) during the procedure. A computed tomography (ct) scan was performed and the results confirmed no air was present in the patient's brain. The user facility notes they did not confirm air was injected into the patient during the catheterization procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134243-2020-00001 |
| MDR Report Key | 9645407 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2018-11-14 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 9529959347 |
| 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 | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | DXT |
| Date Received | 2020-01-29 |
| Returned To Mfg | 2020-01-27 |
| Model Number | CVI |
| Catalog Number | 014657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 5000 | 1. Hospitalization; 2. Life Threatening | 2020-01-29 |