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 2020-03-26 for INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035 manufactured by Boston Scientific Corporation.
[187706589]
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187706590]
It was reported that the patient experienced tissue damage. After an premature ventricular ectopy ablation procedure with an intellamap orion high resolution mapping catheter, the patient experienced a mediastinal thermal injury post ablation. During the procedure, radiofrequency (rf) ablation was delivered to the distal coronary sinus (cs) and the adjacent right ventricular outflow tract (rvot). There were no issues during the procedure. Upon discharge, the patient reported chest pain and a computed tomography (ct) chest scan was performed. A mediastinal thermal injury was reported. The orion catheter was left in the descending aorta during ablation. The catheter was disposed of and was therefore not being returned. No device performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03941 |
| MDR Report Key | 9885062 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | 87035 |
| Catalog Number | 87035 |
| Lot Number | 0024235946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-03-26 |