MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-09 for DECANAV ELECTROPHYSIOLOGY CATHETER R7D282CT manufactured by Biosense Webster Inc.
[188862875]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacture reference no: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188862876]
It was reported that a male patient underwent paroxysmal atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis. During an afib procedure at the conclusion of pulmonary vein isolation, a pericardial effusion was diagnosed via (ice) intracardiac electrocardiogram. A pericardiocentesis was performed by the physician to remove 500ml of fluid. The caller reported that the physician stated that the decanav catheter was the cause. The patient was stable at the time of the call and was transferred to the intensive care unit (icu) for observation. The patient was observed for two days and had recovered. The event occurred during the use of biosense webster inc. (bwi) products. Transseptal was performed with baylis transseptal needle. Ablation was performed prior to discovery of the effusion. There was no evidence of steam pop. The flow settings on an irrigated catheter (unspecified) was 2ml. There were no error messages on biosense webster equipment. Graph, dashboard and visitag features were used for force visualization. Visitag parameters were 3mm, 3 seconds, 25%, 3 grams with time for coloring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00372 |
| MDR Report Key | 9805102 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2020-01-15 |
| Date Added to Maude | 2020-03-09 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | BIOSENSE WEBSTER INC (JUAREZ) |
| Manufacturer Street | CIRCUITO INTERIOR NORTE 1820PARQUE INDUSTRIAL SALVACAR |
| Manufacturer City | JUAREZ 32599 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32599 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DECANAV ELECTROPHYSIOLOGY CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-09 |
| Model Number | R7D282CT |
| Catalog Number | R7D282CT |
| Lot Number | 30336973M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSENSE WEBSTER INC |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-09 |