MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-10-17 for BIOSNDSTR10 SNDSTR10 manufactured by Sterilmed, Inc..
[15124950]
It was reported that the device had a defective steering mechanism. The device was replaced and the procedure was continued and subsequently completed. Ther were no patient consequences. This report is being filed for the findings upon investigation. It was later reported that the issue ws discovered almost immediately during mapping. No breach in the device insulation was noticed during the procedure. The device was placed on the back table after being replaced.
Patient Sequence No: 1, Text Type: D, B5
[15341435]
Final device investigation found that the device was returned with a portion of the outer coating torn/worn/scratched away exposing the wire braiding and creating rough surfaces. The device was coiled and had several kinks in the length of the shaft. Upon evaluation, the device did not pass the straightness (centerline) test, which was possibly due to the manner in which the device was returned. The mobility of the device was also affected; the device did not fully deflect as intended. The device was electrically tested and failed the acoustic verification/calibration test, but passed all other electrical testing including hi-pot, signal strength and ultrasound testing. The damage to the outer coating of the shaft was possibly due to the device being packaged for return without being adequately secured causing excess friction during return shipping. The device history record was reviewed, and no discrepancies were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00181 |
| MDR Report Key | 4188050 |
| Report Source | 00 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-06-02 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-10-24 |
| 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 | 2014-10-17 |
| Returned To Mfg | 2014-06-17 |
| Model Number | BIOSNDSTR10 |
| Catalog Number | SNDSTR10 |
| Lot Number | 1704304 |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-17 |