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 MIFI OPEN-IRRIGATED ABLATION CATHETER 87047 manufactured by Boston Scientific Corporation.
[182920157]
The device has been evaluated by boston scientific. Visual analysis of the returned device found dried body fluid found on the handle, main shaft and distal end. 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. Functional analysis was performed which indicated no abnormal resistance was felt when actuating the steering mechanism. The device's lumen was leak tested using an pressure decay test system set to 107 psi, and a touhy bourst (tb) seal for sealing the irrigation holes and mini electrodes. 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 each time, indicating a serious leak in the lumen. X-ray found a length of wire or fiber resting on top of a section of lumen inside the handle. The wire is surrounded by dried fluid. The handle was opened. Confirmed a short length of wire resting on top of the lumen and is surrounded by dried fluid and rust. The wire is rigid and appears to be the same gauge as steering wire, not signal wire. Also found dried saline throughout the handle interior and on the pcb rear connector. A syringe filled with saline was connected to the luer fitting. When the plunger was depressed, saline leaked out from under the adhesive that secures the lumen to the handle.
Patient Sequence No: 1, Text Type: N, H10
[182920158]
Reportable based on analysis completed on 5mar2020. A nav mifi oi was used in a myocardial ablation procedure. The catheter was placed inside the body but just before energization was started the generator lost recognition of the catheter. The procedure was completed by replacing that catheter with no patient complications being reported. Returned device analysis revealed a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02927 |
| MDR Report Key | 9817568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-05-24 |
| 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 MIFI OPEN-IRRIGATED ABLATION CATHETER |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023850203 |
| 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 |