MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-07-27 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1103944]
It was reported the ultrawand device was primed and therapy delivered at 360 ml/hr per the new instructions for use (ifu). The ultrawand began to pop with a temperature reading of 80c. The nurse then increased flow rate above ifu recommendation to 400 ml/hr which did not resolved the issue. There were no error messages during this case. The physician stated the pt suffered an atrial injury within the "footprint" of the device, requiring a repair stitch be placed. The physician voiced his concern about the popping and indicated he believed the injury was directly caused by the popping of the wand. The pt was in the icu on balloon pump post surgery.
Patient Sequence No: 1, Text Type: D, B5
[8352960]
We are awaiting device receipt. A f/u medwatch report will be submitted upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00007 |
| MDR Report Key | 1422920 |
| Report Source | 05,06,07 |
| Date Received | 2009-07-27 |
| Date of Report | 2009-07-06 |
| Date of Event | 2009-07-06 |
| Date Facility Aware | 2009-07-06 |
| Date Mfgr Received | 2009-07-07 |
| Date Added to Maude | 2009-07-31 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | PHYLLIS PIET-HUGHES |
| Manufacturer Street | ONE ST. JUDE MEDICAL DR. |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAWAND LP |
| Generic Name | ULTRAWAND LP |
| Product Code | NTB |
| Date Received | 2009-07-27 |
| Model Number | NA |
| Catalog Number | 12400 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-27 |