MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for WOVEN DIAGNOSTIC ELECTRODE CATHETER manufactured by Boston Scientific Corporation.
[184891993]
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
[184892014]
It was reported that the patient died. During an ablation procedure, left atrial mapping was performed with the intellamap orion high resolution mapping catheter. Ablation was performed with non-boston scientific cryoballoon ablation catheter. Following a re-map, the electrophysiologist (ep) performed a transthoracic echocardiogram (tee) and noted a significant pericardial effusion despite normal hemodynamic monitoring. Anticoagulation therapy was immediately reversed and further imaging intervention was performed (tee) and pericardium was accessed. Blood was removed from the pericardium and transfused back to the central line. The patient continued to deteriorate and cardiothoracic (ct) surgeon was consulted. After further deterioration, cardiopulmonary resuscitation (cpr) and life-saving efforts were initiated. Eventually the ct surgeon opened the chest and surveyed for a cardiac perforation without success. After some time, the ep called time of death. At the time, the physician did not attribute the event to any specific product. The catheter was disposed of and was not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03864 |
| MDR Report Key | 9878898 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-25 |
| 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 | WOVEN DIAGNOSTIC ELECTRODE CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-25 |
| 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. Death; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-25 |