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 2020-03-24 for INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035 manufactured by Boston Scientific Corporation.
[184739272]
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
[184739273]
It was reported that the patient experienced a cardiac tamponade and perforation. During a redo pulmonary vein isolation (pvi) ablation procedure, with an intellamap orion high resolution mapping catheter, an intellanav mifi open-irrigated ablation catheter, a dynamic xt electrode catheter and two non-boston scientific 8. 5f sheaths, a perforation of left atrium near the base of the appendix occurred. Aspiration was not sufficient, so surgical intervention was required. The perforation closed and the patient was stabilized. It was suspected the intellanav mifi open-irrigated ablation catheter caused the tamponade as the puncture was found to be at the base of that appendage. Since the issue was noticed at the very end of the procedure, after cardioversion, it was considered less likely this was caused by the transeptal puncture. It was not known if it was due to hard pushing or too much ablation. The physician didn't note any resistance maneuvering any of catheters. All of the devices used were disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03772 |
| MDR Report Key | 9873566 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Model Number | 87035 |
| Catalog Number | 87035 |
| 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 | 9 | 1. Required No Informationntervention | 2020-03-24 |