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 2009-06-15 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1232034]
It was reported, the pt was undergoing a concomitant open heart procedure of maze/mvr/avr/cabg and an epicor procedure was performed. During wand ablation with approximately 12 seconds remaining in the run, the physician felt a "popping sensation" and felt a vibration. At that moment, the acs unit was registering 80 degrees c. Infusion of ultrawand saline was administered via an iv pump and was set at 360cc rate throughout the wand procedure. The physician was not exerting any excess force to the wand during the ablation run. At the 12 second remaining point of the run, the physician withdrew the wand from the heart. Visually, steam and bubbling were coming from wand. There were no pt complications. To that end, the pt was in normal sinus rhythm and hemodynamically stable. Visual inspection of the wand ablation line by the physician noted no tissue damage and/or injury. An avr procedure was successfully performed utilizing the st jude epic valve, performed a mvr procedure utilizing a st jude epic valve and proceeded to perform a cabg procedure. The final result was successful and safe (without incident to the pt). Hospital has a specific protocol in product/incident reporting. The wand lot #89703 and acs unit lot # u000105 have been temporarily sequestered and given to biomed. Products will be released to st jude upon conclusion of internal hospital protocol. The hospital does have another acs unit in-house to be utilized for upcoming ablation cases. Products used as follows: acs unit lot # u000105, cinch uc-lp-9 lot # 24868. All other st. Jude medical products used in the case exhibited no issues.
Patient Sequence No: 1, Text Type: D, B5
[8474632]
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 | 3003870001-2009-00005 |
| MDR Report Key | 1471723 |
| Report Source | 05,06,07 |
| Date Received | 2009-06-15 |
| Date of Report | 2009-06-15 |
| Date of Event | 2009-06-05 |
| Date Facility Aware | 2009-06-05 |
| Date Mfgr Received | 2009-06-09 |
| Date Added to Maude | 2009-11-10 |
| 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 | 3 |
| 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 | 2009-06-15 |
| 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 | 2009-06-15 |