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 2020-03-10 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.
[182731931]
Visual inspection revealed that the main shaft is torn open immediately proximal from the butt bond. Dried body fluid found inside the tear. Dried body fluid also 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. No abnormal resistance was felt when actuating the steering mechanism. X-ray confirmed the tear in the shaft occurred along the proximal edge of the butt bond sleeve. The distal end tubing was opened. Dried body fluid debris was found throughout the distal end cavity.
Patient Sequence No: 1, Text Type: N, H10
[182731932]
Reportable based upon analysis completed on 18feb2020. A nav mifi oi was used in a right atrial flutter ablation procedure. As the procedure was almost completed, the physician wanted to put in an additional burn when the generator gave a temperature error. The temperature of the catheter was 54 degrees celsius. The physician decided to end the procedure. The catheter was removed and checked for clots. No patient complications were reported. Analysis revealed that the shaft was torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02846 |
| MDR Report Key | 9811322 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-06-13 |
| 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 |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023950209 |
| 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 |