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 2015-08-31 for BIOSNDSTR10 manufactured by Sterilmed, Inc..
[24536528]
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
[24536529]
It was reported that during an afib case, a perforation was noticed when the patient's blood pressure dropped and confirmed through an ultrasound. It was reported that the medical intervention provided was a pericardiocentesis and 1680cc of fluid was removed and then the patient was moved to the or for surgical intervention to fix the perforation. The patient was reported to be stable when he left the ep lab. The patient required extended hospitalization because of the adverse event. Event occurred during ablation. Overall ablation time at the site of injury was 40 seconds. The last ablation cycle time was 10 seconds. Noted settings used at the time of injury are power mode-temp warning 37 and cut off 40, imp cut off 250 injury noted temp 28-29*c, power 30w, imp 250.
Patient Sequence No: 1, Text Type: D, B5
[27467488]
The device was returned and was subjected to full electrical testing. The device failed its acoustic verification testing. Records show that the device passed this and all tests prior to being sent to the account. No conclusion could be made as to the root cause of this failure as the device was noted to be used during the procedure. The device history record was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00041 |
| MDR Report Key | 5041707 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-06-24 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-08-31 |
| 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 SUITE 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 | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2015-08-31 |
| Model Number | BIOSNDSTR10 |
| Catalog Number | BIOSNDSTR10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-31 |