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 2015-08-11 for ETHMSM20 manufactured by Sterilmed, Inc..
[22581093]
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.
Patient Sequence No: 1, Text Type: N, H10
[22581094]
It was reported that during a peripheral artery arthrectomy endovascular left axillary femoral bypass graft procedure, the subclavien artery was lacerated causing excessive bleeding and loss of control of the surgical site. Total blood loss was 20cc and was controlled using a ligasure sealer the incident extended the procedure an extra 20 minutes. It was reported that the subclavien artery was difficult to access. A request for additional information reported that the clip scissored on the first firing of the device. The patient was discharged with no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00040 |
| MDR Report Key | 4992487 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-07-16 |
| Device Manufacturer Date | 2015-03-25 |
| Date Added to Maude | 2015-08-11 |
| 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 | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE. 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2015-08-11 |
| Model Number | ETHMSM20 |
| Catalog Number | ETHMSM20 |
| Lot Number | 1848666 |
| Device Expiration Date | 2016-03-25 |
| 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 | 2015-08-11 |