MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-09 for FIRMAP? CATHETER manufactured by St. Jude Medical.
[176849719]
Concomitant device(s): swartz braided introducer. The results of the investigation are inconclusive since the device was not returned for analysis.? Additionally, the device history record (dhr) was unable to be reviewed as a lot number was not provided.? Based on the information received, the cause of the reported incidents could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[176849720]
Related manufacturing ref: 3005334138-2020-00004. The following was published in the journal of cardiovascular electrophysiology titled, "single-center experience of the firm technique to ablate paroxysmal and persistent atrial fibrillation" by henley, patrick, et al. : four major complications occurred over the course of the study. There were three transient ischemic attacks and one cerebrovascular accident. No neurological sequelae were noted on follow-up after these events. Interestingly, all four of these patients were prescribed rivaroxaban before the procedure. All of these patients took their last dose of rivaroxaban the day before the procedure. These patients were switched to another new oral anticoagulant medication or warfarin on discharge or follow-up. Three groin hematomas, one fever and two urinary-tract infections and one incidence of epididymitis were also noted as minor complications in the acute post procedural setting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00008 |
| MDR Report Key | 9572091 |
| Report Source | LITERATURE |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-09 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRMAP? CATHETER |
| Generic Name | CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |