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 2020-03-12 for INTELLANAV OI 87045 manufactured by Boston Scientific Corporation.
[183102420]
The device was returned for analysis. Visual inspection showed the butt bond was compromised. There was a gap between the proximal and distal shaft and dried body fluid was present along the seam. Continuity checks revealed no electrical opens as checked manually using a multi-meter and breakout box. All electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical. However, there was a resistive short between the tip, sensor 1, sensor 2, and ring 1 in all curve configurations. Lcr test was performed and confirmed that the magnetic sensor was within specifications. 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. The lumen pressure decay was measured three times, starting with 107 psi, with re-seating of the tb seal between each test. Pressure decay values were 0. 1436 psi, 0. 1056 psi and 0. 1026 psi. These values are within an acceptable limit.
Patient Sequence No: 1, Text Type: N, H10
[183102421]
Reportable based on device analysis completed on 13feb2020. It was reported that tracking/accuracy issues occurred. Halfway through an ablation procedure with an intellanav oi ablation catheter, magnetic tracking of the catheter was lost. The procedure was completed with another of the same device and there were no reported patient complications. Returned device analysis revealed the butt bond between the insulations of the distal and proximal shafts was compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03034 |
| MDR Report Key | 9823570 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2020-03-12 |
| 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 OI |
| Generic Name | INTELLANAV OI |
| Product Code | OAE |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2019-12-11 |
| Model Number | 87045 |
| Catalog Number | 87045 |
| Lot Number | 0024228116 |
| 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 | 2020-03-12 |