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 2020-03-04 for INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035 manufactured by Boston Scientific Corporation.
[182207330]
Visual inspection of the device showed that the device has saline on the main shaft and in the distal tip. The magnetic sensor is cracked at. 245 inches. X-ray confirmed broken sensors. No electrical open failures that appeared in electrodes. No un-allowed shorts occurred in the electrodes.
Patient Sequence No: 1, Text Type: N, H10
[182207331]
Reportable based upon analysis completed on 05feb2020. It was reported that a sensor error occurred. During a procedure with a intellamap orion catheter when inserted into the heart, an error stating that the sensor magnetic on orion was broken. The catheter was exchanged and the issue was resolved with no patient complications being reported. Upon analysis it was noted that the magnetic sensor was physically cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02575 |
| MDR Report Key | 9787347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-09-02 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2020-03-04 |
| 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 | INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2019-12-17 |
| Model Number | 87035 |
| Catalog Number | 87035 |
| Lot Number | 0023269712 |
| Device Expiration Date | 2020-01-30 |
| 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 | 2020-03-04 |