MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-03-26 for ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELL 12546 manufactured by St. Jude Medical.
[15414698]
It was reported that a patient with a history of af and ischemic coronary disease was to receive cabg surgery and ablation. When the ablation was to be performed, during manipulation and placement of the ultracinch 11, the patient became severely hypotensive and bradycardic. Consequently, the ablation could not be performed. The patient was put onto the heart-lung machine and cabg was performed as planned. The hospital stay was not prolonged due to the event.
Patient Sequence No: 1, Text Type: D, B5
[15656177]
We were unable to evaluate the product involved in this incident since no components of the device were returned for analysis. Review of the device history record was not done as the lot number of the device is not known. Based on the information provided to st. Jude medical, the cause for the reported bradycardia and hypotension remains unknown. Date report submitted to fda by manufacturer: (b)(6)2010. Date the initial reporter provided the information to the manufacturer: (b)(6)2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2010-00003 |
| MDR Report Key | 1649765 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-03-26 |
| Date of Report | 2010-03-02 |
| Date of Event | 2009-10-13 |
| Date Facility Aware | 2010-03-02 |
| Date Added to Maude | 2010-11-30 |
| 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 | SETH KERSTEN |
| 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 | ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELL |
| Generic Name | ULTRACINCH LP - 11 DEVICE |
| Product Code | NTB |
| Date Received | 2010-03-26 |
| Model Number | NA |
| Catalog Number | 12546 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-03-26 |