MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-11-20 for BIOSNDSTR10 SNDSTR10 manufactured by Sterilmed, Inc..
[5032079]
It was reported that the patient's blood pressure dropped during the case. Access had been obtained, a coronary sinus catheter had been placed into the cs under fluoroscopic guidance. Ultrasound images had been obtained and incorporated into a carto map of the left atrium. A single rf application had been applied. Cartosound confirmed cardiac tamponade. Pericardiocentesis was performed and more than 900 cc of fluid was removed. The patient was stabilized. The procedure was completed after the tamponade without any further injury. It was also reported that initially there was extreme difficulty steering the device before the tamponade occurred and that the device was exchanged with another device with no issue after the tamponade. The replacement was made in order to visualize the pericardial space for evaluation of the volume of fluid present. The surgeon did not believe that the device caused the cardiac tamponade despite the difficulty in steering. It was believed that the issue was a combination of how the ablation catheter was moved during mapping combined with the sheath.
Patient Sequence No: 1, Text Type: D, B5
[12538261]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after device investigation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00190 |
| MDR Report Key | 4275861 |
| Report Source | 00 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-22 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2014-11-26 |
| 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 | TRICIA SCHRATER |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND |
| Product Code | OWQ |
| Date Received | 2014-11-20 |
| Model Number | BIOSNDSTR10 |
| Catalog Number | SNDSTR10 |
| Lot Number | 1772136 |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2014-11-20 |