MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-10 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1258445]
It was reported that the physician was doing his first lp case. During the ultracinch portion of the procedure an inadvertent puncture of the ivc occurred during dissection which was easily repaired. The surgeon stated that the damage to the ivc was not caused by the epicor device. The physician then proceeded to ablate with the ultrawand. The tubing and wand were both primed to gravity and the pump was set to 120ml/hr. The pump was started without issue and the ultrawand was correctly placed and the ablation was initiated. The temperatures were steady (no higher than 85c on the screen) in accordance with a textbook ablation cycle. With approximately 20 seconds to go, there was a loud "popping" sound and steam was coming from the ultrawand device. The surgeon removed the ultrawand from the patient's tissue and inspected the area; no visible harm was noted. The epicor portion of the case was concluded. The physician was unsure what caused the popping sound. The patient was reportedly ok; the extent of steaming was undetermined. The sjm fce was present during the procedure. The surgeon feels that there is a potential for injury from steam from the wand. An ultracinch, ultrawand and pas kit were used during the procedure. It is unknown what other devices were used. Sjm product surveillance was not notified of this event until 6/8/2009.
Patient Sequence No: 1, Text Type: D, B5
[8309162]
We are in the process of investigating this event. A follow-up report will be submitted upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00004 |
| MDR Report Key | 1472474 |
| Report Source | 05,06 |
| Date Received | 2009-06-10 |
| Date of Report | 2009-06-10 |
| Date of Event | 2009-05-05 |
| Date Facility Aware | 2009-05-05 |
| Date Mfgr Received | 2009-06-08 |
| Date Added to Maude | 2009-10-20 |
| 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 DRIVE |
| 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 | 2009-06-10 |
| 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 | 2009-06-10 |