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 2020-03-05 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.
[182211599]
Visual inspection revealed dried body fluid found on the handle, main shaft and distal end. The dried saline was found on the distal end and inside several irrigation ports. Electrical tests revealed that while manipulating the shaft, continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box. All electrodes, sensor and thermocouple resistances measured in specification and were typical. Functional inspection revealed 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 pressure leak test revealed the device's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst seal for sealing the irrigation holes and me's. The lumen pressure decay was measured three times, with re-seating of the tb seal between each test. Lumen pressure decay values were gross fail, gross fail and gross fail psi, which indicated a leak in the lumen. The x-ray inspection revealed that the x-ray found dried fluid debris adjacent to the cooling lumen inside the handle. Device dissection revealed the handle was opened to investigate a possible lumen leak. A crack was found in the adhesive that secures the irrigation tubing to the lumen. Dried saline was found inside the crack. Also found dried saline between several solder joints on the rear connector pcb. A metriq pump was connected to the luer fitting. Within seconds at a flow rate of 2ml/min, saline was observed exiting the crack in the adhesive.
Patient Sequence No: 1, Text Type: N, H10
[182211600]
Reportable based on device analysis completed on 06feb2020. It was reported that there a high temperature error. During an denovo pulmonary vein isolation procedure to treat atrial fibrillation an nav mifi oi was selected for use. The nav mifi oi was used for about 15-20 minutes and rf was automatically stopped because of a high temperature error on the maestro. After clearing the error, the generator rebooted itself and got the "finding catheter" prompt. They power cycled the maestro and there was significant noise on the mifis. They unplugged and replugged the ablation cable and did not resolve the issue. They tried a new cable and there were no ablation signals coming from the catheter. They replaced the catheter which resolved the issues and the procedure was completed successfully. There was no patient complications. However, device analysis revealed a crack in the adhesive that joins the irrigation tubing to the cooling lumen allowed saline to leak into the interior of the handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02617 |
| MDR Report Key | 9793237 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-05-21 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023827401 |
| 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 | 2020-03-05 |