MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-04-11 for ACU10135936 manufactured by Sterilmed, Inc..
[42333832]
It was reported that the device will not be returned to the manufacturer. No device history report was reviewed as no lot number was given.
Patient Sequence No: 1, Text Type: N, H10
[42333833]
It was reported that reported that a cardiac perforation was noticed after the physician was not able to use the c3 mapping module. No medical intervention was provided. It was reported that patient was in stable condition. The actual device is reported as not being returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00020 |
| MDR Report Key | 5566841 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-11 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-03-01 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-04-11 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2016-04-11 |
| Model Number | ACU10135936 |
| Catalog Number | ACU10135936 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-11 |