MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for ARTIS Q AV11C manufactured by Siemens Healthcare Gmbh.
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There were image quality issues with our imaging equipment located in neuro interventional radiology. Per dr. , "the catheter appeared to be in the artery, but it was actually in the aneurysm. If continued to proceed with the procedure with the current acquired images; i would have ruptured the aneurysm and killed the patient". The pictures identify that the microcatheter is not in the aneurysm due to the black marker at the end of the microcatheter. The image shows a white distal marker that should not even exist; however, that was the true placement of the distal tip of the microcatheter. Physician was unable to identify true microcatheter placement unless visualized under a native live fluoro image. Risk to patient was significant. Manufacturer response for siemens artis av11c, (brand not provided) (per site reporter). We have had multiple issues with this particular room and siemens has not been able to fix it. We need this escalated up before someone dies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8284790 |
| MDR Report Key | 8284790 |
| Date Received | 2019-01-29 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-20 |
| Report Date | 2018-12-26 |
| Date Reported to FDA | 2018-12-26 |
| Date Reported to Mfgr | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| 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 | RISK MANAGER |
| 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 | ARTIS Q |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-01-29 |
| Model Number | AV11C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |