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 2017-11-20 for N/A R10438577 manufactured by Sterilmed, Inc..
[92587289]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history was unable to be reviewed as no lot not was supplied by the customer for this device. Reporter phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92587290]
It was reported that during an afib case, a pericardial effusion was noticed. No ablation was performed prior to noticing the injury. The pericardial effusion was confirmed by ice. Caller reported that the medical intervention provided was a pericardiocentesis and 1. 2 liters. It was believed by the staff that the pericardial effusion was caused by human factors and that the device functioned as it should.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00075 |
| MDR Report Key | 7046637 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-11-20 |
| 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 STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | IMAGING CATHETER |
| Product Code | OWQ |
| Date Received | 2017-11-20 |
| Model Number | R10438577 |
| Catalog Number | R10438577 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-20 |