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 2009-04-24 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.
[1204875]
It was reported the patient was undergoing a concomitant open heart procedure of maze/avr. The maze procedure was performed utilizing an epicor sizer and an ultracinch device without difficulty. The physician proceeded to utilize an ultrawand lp device. During 120 second ultrawand ablation at approximately 20 seconds remaining, an audible "popping sound" was heard coming from the ultrawand. A vibration was heard and felt. The physician immediately removed the ultrawand device from the patient and a "hole" was noted in the heart in the proximity of the av grove/ventricle. The physician immediately placed the patient on pump and then proceeded to correct the problem by utilizing a bovine sjm pericardial patch. The physician then proceeded to implant a sjm epic tissue valve in the aortic position. The case proceeded and the patient then came off the pump. The patient was in normal sinus rhythm with stable hemodynamics following the procedure. Several hours post procedure, the physician indicated to the sjm rep, that the patient continued to be both in normal sinus rhythm and hemodynamically stable. The perioperative tee assessment indicated: a successful patch repair with no leak. A successful implantation of aortic valve demonstrating good coaptation and no leak. Noted mitral regurge. The physician feels added mitral regurge was a direct result of having to patch the hole that was incurred.
Patient Sequence No: 1, Text Type: D, B5
[8325001]
The product is currently in the possession of the hospital. A follow up report will be submitted upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2009-00003 |
| MDR Report Key | 1369326 |
| Report Source | 05,06,07 |
| Date Received | 2009-04-24 |
| Date of Report | 2009-04-24 |
| Date of Event | 2009-04-17 |
| Date Facility Aware | 2009-04-17 |
| Date Mfgr Received | 2009-04-20 |
| Device Manufacturer Date | 2008-10-15 |
| Date Added to Maude | 2009-05-01 |
| 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 | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| 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 | 2009-04-24 |
| Model Number | NA |
| Catalog Number | 12400 |
| Lot Number | NA |
| Device Expiration Date | 2009-10-15 |
| 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 | 2009-04-24 |