MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-16 for ACUNAV DX ULTRASOUND CATHETER 10135936 manufactured by Sterilmed.
[5383104]
During the lead extraction procedure, the acuson catheter acunav dx ultrasound 8fr issued a catheter error message "exceed thermal limit" - this catheter is a reprocessed device for single use processed by sterilmed, inc. Catheter needed to be replaced to continue procedure. For the ep procedure of pacemaker lead extraction / reimplantation of pacemaker leads, the pt was intubated and under the care of anesthesia for general anesthesia, had an arterial line for hemodynamic monitoring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040372 |
| MDR Report Key | 4451228 |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-16 |
| Date of Event | 2015-01-06 |
| Date Added to Maude | 2015-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUNAV DX ULTRASOUND CATHETER |
| Generic Name | ULTRASOUND CATHETER 8FR |
| Product Code | OWQ |
| Date Received | 2015-01-16 |
| Model Number | 10135936 |
| Lot Number | 182 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED |
| Manufacturer Address | MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-16 |