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 2008-06-05 for AGILIS INTRODUCER, UNKNOWN NA manufactured by St. Jude Medical.
[15778444]
An agilis sheath was one of two transseptal sheaths used in the atrial fibrillation ablation. A biosense webster lasso was used in the left atrium along with a cool path catheter. The ensite system was used for navigation in conjunction with a navx patch. After completing the ablation, it was noted that a pericardial effusion was present. A cardiologist was contacted and a pericardiocentesis was performed. The physician reported that over 500 ml of fluid was withdrawn from the pericardium in the lab. The pigtail was left in the pt overnight without any additional drainage. The pt remained stable throughout. The pt did not exhibit any additional problems as a result of the injury. The physician does not believe the injury was caused by the navx patch, ensite system nor the agilis sheath. The cause for the perforation could not be determined. No lot numbers are available for the biosense webster lasso or cool path catheters. No serial or lot numbers were provided for the ensite system or the navx patch. The ensite system was functioning normally.
Patient Sequence No: 1, Text Type: D, B5
[15802692]
The agilis device was not returned for analysis and review of the device history record was not possible as the lot number is unknown. Based on the information provided, the cause for the reported perforation remains unknown. It should be noted dr (b)(6) does not believe the injury was caused by the navx patch, ensite system nor the agilis sheath.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182269-2008-00394 |
| MDR Report Key | 2975848 |
| Report Source | 05,06,07 |
| Date Received | 2008-06-05 |
| Date of Report | 2008-06-05 |
| Date of Event | 2008-05-20 |
| Date Facility Aware | 2008-05-20 |
| Date Mfgr Received | 2008-05-20 |
| Date Added to Maude | 2013-02-26 |
| 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 | 0 |
| Manufacturer Contact | JOHN RISSE |
| Manufacturer Street | 14901 DEVEAU PL. |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 14901 DEVEAU PL. |
| Manufacturer City | MINNETONKA MN 55345212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55345 2126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGILIS INTRODUCER, UNKNOWN |
| Generic Name | AGILIS INTRODUCER, UNK. |
| Product Code | OEX |
| Date Received | 2008-06-05 |
| Model Number | UNKNOWN |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| 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 | MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-05 |