MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for THERAPY? COOL PATH? DUO ABLATION CATHETER manufactured by St. Jude Medical, Inc..
[187933088]
Concomitant devices: flexibility catheter, event date unknown. The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible as the lot number is unknown. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[187933089]
Related manufacturer reference number: 3005334138-2020-00101. The following was published in the international journal of cardiology in an article titled? Elongation of the high right atrium to coronary sinus conduction time predicts the recurrence of atrial fibrillation after radiofrequency catheter ablation? By kanemaru y, arima y, kaikita k, et al. , 18 november 2019. ? The impact of intra-atrial conduction delay on the recurrence of atrial tachyarrhythmia after radio frequency catheter ablation (rfca) has not been fully elucidated. In this study, 155 af patients who were in sinus rhythm at the start of rfca were analyzed at the kumamoto university hospital from january 2011 to march 2017. The conduction time from the onset of the earliest atrial electrogram at the high right atrium (hra) to the end of the latest electrogram at the coronary sinus (cs) during sinus rhythm was defined as hra-cs conduction time. Pulmonary vein isolation (pvi) was performed followed by linear roof lesion and complex fractionated atrial electrogram (cfae) ablation until af termination. Of the 155 patients, four experienced esophageal injuries. The conclusion was that the hra-cs conduction time was the primary influencing factor that predicted the recurrence of atrial tachyarrhythmia after catheter ablation. (https://doi. Org/10. 1016/j. Ijcard. 2019. 10. 044).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030404-2020-00018 |
| MDR Report Key | 9812310 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-10 |
| 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 | 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, INC. |
| Manufacturer Street | 2375 MORSE AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERAPY? COOL PATH? DUO ABLATION CATHETER |
| Generic Name | IRRIGATED ABLATION CATHETER |
| Product Code | OAE |
| Date Received | 2020-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 2375 MORSE AVE IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |