MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-01 for BIOSNDSTR10 manufactured by Sterilmed, Inc..
[5838654]
Additional information received : it was reported that it was believed that the clot was discovered after insertion of the femoral lines.
Patient Sequence No: 1, Text Type: D, B5
[13346877]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21850010]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after device evaluation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
[21929273]
It was reported that during an idvt case, a large clot in the pulmonary artery was discovered. It was unknown whether the clot was already there or was dislodged when the axis was obtained and the device was advanced. The case was aborted and the medical intervention provided was a radiology consultation. The patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[24665791]
The device history record was reviewed, and no discrepancies were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00025 |
| MDR Report Key | 4808670 |
| Report Source | 05,07 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-05-07 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-07-01 |
| Device Manufacturer Date | 2015-01-21 |
| Date Added to Maude | 2015-06-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY |
| 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 | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2015-06-01 |
| Model Number | BIOSNDSTR10 |
| Catalog Number | BIOSNDSTR10 |
| Lot Number | 1823595 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-06-01 |