MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-23 for INTELLANAV OPEN-IRRIGATED 87045 manufactured by Boston Scientific Corporation.
[184539406]
It was reported that the catheter was sensing temperature lower than expected. During an ablation procedure for typical flutter, the physician inserted the intellanav open-irrigated catheter into the chamber. Distal temperature was about 31-32 degree celsius without ablation. With ablation energy on at 30 watts in power control mode, the temperature was about 19-20 degree celsius. The pump flow setting was 25-30 ml/min. The temperature sensor was under detecting. No error codes were displayed. No patient complications occurred. The procedure was completed with a new catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03692 |
| MDR Report Key | 9865995 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2020-03-23 |
| 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 OPEN-IRRIGATED |
| Generic Name | INTELLANAV OI |
| Product Code | OAD |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 87045 |
| Catalog Number | 87045 |
| Lot Number | 0023992720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-23 |