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 2020-03-11 for INTELLANAV OPEN-IRRIGATED 87045 manufactured by Boston Scientific Corporation.
[182919374]
The device was returned for analysis. Visual inspection showed there was a gap in the butt bond. There was dried saline in the luer and dried body fluid on the shaft. Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box. All electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical. The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical. Lcr test was performed and confirmed that the magnetic sensor was within specifications. The steering knob and the tension control knob functioned properly on both lock and unlock positions. No abnormal resistance was felt when actuating the steering mechanism. The device's lumen was leak tested using an isaac pressure decay test system. The lumen pressure decay was measured three times, starting with 107 psi, with re-seating of the tb seal between each test. Pressure decay values were 0. 2241 psi, 0. 1954 psi and 0. 1867 psi. These values are within an acceptable limit. A slit in the distal end insulation tubing was made and dried saline crystals were visible in the interior of the shaft.
Patient Sequence No: 1, Text Type: N, H10
[182919375]
Reportable based on device analysis completed on 11feb2020. It was reported that tracking/accuracy issues occurred. During an ablation procedure to treat atrial fibrillation, after successful mapping, an intellanav open-irrigated catheter was ablating in the femoral artery when they lost magnetic tracking. The catheter disappeared in rhythmia. The procedure was completed with a replacement device. No patient complications were reported. However, device analysis revealed the butt bond between the insulations of the distal and proximal shafts was compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02920 |
| MDR Report Key | 9817368 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-02-05 |
| Date Added to Maude | 2020-03-11 |
| 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 OPEN-IRRIGATED |
| Generic Name | INTELLANAV OI |
| Product Code | OAD |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2019-12-16 |
| Model Number | 87045 |
| Catalog Number | 87045 |
| Lot Number | 0023297492 |
| 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 | 2020-03-11 |