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 2020-02-25 for INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER 87047 manufactured by Boston Scientific Corporation.
[181175021]
The catheter received by boston scientific has a lot number of 0023268662, which is different from the reported lot number of 0023611740. Multiple good faith efforts were sent but no responses were received. The reported failure was confirmed through investigation analysis. Electrode ring 3 seal is noted to be comprised on the proximal side with dried body fluid on both edges of the ring and on the shaft. Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box and all electrode/ thermocouple/magnetic sensor 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 all values are within an acceptable limit. A slit in the insulation of the distal section was made and dried body fluid was noted on inside of the tubing and on the signal wires. Evidence of fluid ingress in the distal end is most likely due to a compromised electrode ring 3 seal. Fluid ingress is known to affect signal and tracking integrity and is the most likely reason for the tracking issues reported by the field.
Patient Sequence No: 1, Text Type: N, H10
[181175022]
Reportable based on device analysis completed on 30 january 2020. It was reported that complete loss of tracking was observed. During an ablation procedure to treat left atrial flutter an intellanav mifi open-irrigated ablation catheter was selected for use. Magnetic tracking was lost and the error message "magnetic sensor is either disconnected or broken" was noted. The procedure was completed by exchanging the catheter. No patient complications were reported and the patient's current condition is fine. However, device analysis revealed evidence of fluid ingress in the distal end most likely due to a compromised electrode ring seal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02079 |
| MDR Report Key | 9750828 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Returned To Mfg | 2019-12-10 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023268662 |
| 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 | 2020-02-25 |