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 2020-02-26 for INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER 87047 manufactured by Boston Scientific Corporation.
[181185855]
The reported failure for the detached luer was confirmed through investigation analysis. Visual inspection noted that the luer is missing and was not returned. The device was returned in a slight right curve position. There is dried body fluid on the irrigation tubing, handle, shaft, and tip. Continuity checks revealed no electrical opens or shorts and all electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical. The measurements were repeated in the right and left curve configuration and all measurements were within specifications and typical. The luer was not attached to the catheter upon return. The most likely reason for the temperature errors reported by the field was due to the inability of the device to irrigate. The complaint investigation conclusion code is design inadequate for purpose. The following results: the luer was not attached to the catheter upon return. The most likely reason for the temperature errors reported by the field was due to the inability of the device to irrigate.
Patient Sequence No: 1, Text Type: N, H10
[181185856]
It was reported that loss of irrigation occurred. During an ablation procedure to treat atrial fibrillation in the right and left subclavian an intellanav mifi open-irrigated ablation catheter was selected for use. An ablation attempt was unsuccessful as an error message for increased temperature of the catheter tip was observed. The physician visually examined the catheter and it was noted that the flushing port of the handle was twisted off and irrigation was not possible. The procedure was completed with another catheter without further complications. No patient complications were reported and the patient's current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02132 |
| MDR Report Key | 9756412 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-02-26 |
| 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 | 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 ABLATION CATHETER |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0024498535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-26 |