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 2009-11-09 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[21785835]
It was reported with approx 25 seconds left in the ablation using the uw-lp-2 ultrawand, the surgeon heard and felt a pop that was followed immediately with a sizzling noise. The physician asked the circulating nurse to pause the ablation and then he inspected the device. The surgeon noted that there was a small hole in the membrane for one of the cells. It was deemed at the time of the error, that the pop was caused by a large air bolus that was created during the swapping of the saline lines from the ultracinch to the ultrawand portion of the ablation sequence. The circulating and scrub nurse thought that all of the air was discharged, although after the incident decided that air was still in the lines. As soon as the surgeon noted the sounds, the temperature was noted to be around 50-55c. After discussing the event, the surgeon asked that the ablation be continued for the remainder of the ablation sequence, which occurred without further incident.
Patient Sequence No: 1, Text Type: D, B5
[21825931]
One lp ultrawand device was returned for eval. Visual inspection revealed no damage to the device. Review of the device history record confirmed this device met mfg requirements prior to shipment. Visual inspection revealed no defects on the returned device. Functional testing confirmed the device passed all in-house testing. No holes were found in either membrane, other than those as designed and manufactured for saline perfusion. It should be noted that the circulating nurse and scrub nurse thought that all of the air was discharged, however, after the incident, decided air was still in the lines. The ultrawand lp instructions for use instruct the user to look for and remove air bubbles. Date report submitted to fda by mfr: 11/9/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00015 |
| MDR Report Key | 1525194 |
| Report Source | 05,06,07 |
| Date Received | 2009-11-09 |
| Date of Report | 2009-10-23 |
| Date of Event | 2009-10-23 |
| Date Mfgr Received | 2009-10-23 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2009-11-13 |
| 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 | KAREN MCKELVEY |
| 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 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAWAND LP |
| Generic Name | ULTRAWAND LP |
| Product Code | NTB |
| Date Received | 2009-11-09 |
| Returned To Mfg | 2009-10-26 |
| Model Number | NA |
| Catalog Number | 12400 |
| Lot Number | NA |
| Device Expiration Date | 2009-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-09 |