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 2015-10-23 for BIO10438577 manufactured by Sterilmed, Inc..
[29046727]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after the device evaluation if the device is received. No lot number was reported so the device history record could not be reviewed for discrepancies.
Patient Sequence No: 1, Text Type: N, H10
[29046728]
It was reported that during an idvt case, a pericardial effusion was noticed during mapping when the catheter was in an incorrect location. The pericardial effusion was confirmed by transthoracic echo. It was reported that the medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed. The patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00050 |
| MDR Report Key | 5171298 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-23 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-10-06 |
| Date Added to Maude | 2015-10-23 |
| 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 | JAY 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 | 2015-10-23 |
| Model Number | BIO10438577 |
| Catalog Number | BIO10438577 |
| 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. Required No Informationntervention | 2015-10-23 |