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 INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER 87047 manufactured by Boston Scientific Corporation.
[182732952]
Visual inspection revealed that the distal end is bent in two locations approximately 52 and 66mm from the end of the distal tip. Dried saline found in the gap between the handle and rear connector. Dried body fluid found on the handle, main shaft and distal end. Dried saline found on distal end and inside several irrigation ports. 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 spec and were typical. The steering knob and the tension control knob functioned properly on both lock and unlock positions. 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, indicating a leak in the lumen. X-ray found dried fluid debris adjacent to the cooling lumen inside the handle. 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 and on the pcb itself. 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
[182732953]
Reportable based on analysis completed on 11feb2020. A nav mifi oi was selected for a procedure however it was noted that the temperature sensor was faulty. The procedure was completed using another device, however, returned device analysis revealed a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02842 |
| MDR Report Key | 9811102 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-09-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0022715794 |
| 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 | 2020-03-10 |