MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.
[183321331]
It was reported that a catheter leak occurred. During an cardiac ablation procedure to treat idiopathic ventricular tachycardia in the left ventricle an intellanav mifi open-irrigated catheter was selected for use. It was noted that the generator had reached 40 degrees celsius and a high temperature error message was observed after several ablation attempts. It was also noted that the catheter was leaking irrigation fluid from the tubing connected to the catheter handle. The procedure was completed by replacing the catheter with another of the same model. No patient complications were reported and the patient's current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2134265-2020-03226 |
MDR Report Key | 9829259 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-13 |
Date of Report | 2020-03-13 |
Date of Event | 2020-02-14 |
Date Mfgr Received | 2020-02-14 |
Device Manufacturer Date | 2019-07-24 |
Date Added to Maude | 2020-03-13 |
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 | TIMOTHY DEGROOT |
Manufacturer Street | 4100 HAMLINE AVENUE NORTH DC A330 |
Manufacturer City | SAINT PAUL MN 55112 |
Manufacturer Country | US |
Manufacturer Postal | 55112 |
Manufacturer Phone | 6515826168 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
Manufacturer City | LA AURORA - HEREDIA |
Manufacturer Country | CS |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INTELLANAV MIFI OPEN-IRRIGATED |
Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
Product Code | OAD |
Date Received | 2020-03-13 |
Returned To Mfg | 2020-02-28 |
Model Number | 87047 |
Catalog Number | 87047 |
Lot Number | 0024160973 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-13 |