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.
[182735384]
Age at time of event: 18 years or older. The device was returned for analysis. Dried body fluid was found on the handle, main shaft and distal end. Dried saline was found on distal end and inside several irrigation ports. Me2 collar had a crack filled with body fluid. 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. No abnormal resistance was felt when actuating the steering mechanism. 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 0. 0997, 0. 0816 and 0. 0707 psi, which were below the maximum acceptable limit of 0. 30 psi. X-ray found no anomalies.
Patient Sequence No: 1, Text Type: N, H10
[182735385]
Reportable based on device analysis completed on 14feb2020. It was reported that the catheter noise occurred. During an ablation procedure for atrial fibrillation, once inserted into the chamber the intellanav mifi open-irrigated ablation catheter showed some noise on the proximal signal. The distal signals were fine. The catheter cable was exchanged, but the issue persisted. A different catheter was then used. The procedure was completed successfully, and there were no serious injuries or adverse patient effects. Device analysis revealed evidence of fluid ingress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02843 |
| MDR Report Key | 9811104 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-05-16 |
| 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 |
| 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 | 2019-12-17 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023804250 |
| 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 |