MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-23 for PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER UNK_PENTARAY manufactured by Biosense Webster Inc..
[176223019]
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer? S ref # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176223020]
It was reported that a (b)(6)-year-old male patient ((b)(6) lbs) with substantial history including myocardial infarction, recent placement of stents, a bypass, low ejection fraction (15-20%) and numerous shocks from his defibrillator the previous two weeks due to episodes of ventricular tachycardia (vt), underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered cardiac arrest (requiring shocks and chest compressions) and death. The patient had a history of ischemic ventricular tachycardia with a low ejection fraction between 15-20% and history of ventricular tachycardia storm. Patient condition was very poor according to the physician and he expressed that this was a dire situation and a final attempt for survivability. Although there was a clear electrocardiogram during the case, patient began to have a decline in pulse and eventually loss in blood pressure suggesting pulseless electrical activity. Transseptal had been completed but there was no effusion by intracardiac echocardiography (ice). Voltage map had been started at that time. There was no evidence for product malfunction during the case and no errors were reported. Ice was utilized during the case and carto sound provided ultrasound imaging appropriately during resuscitation efforts. Despite resuscitative efforts, patient expired. Following the transseptal puncture, while voltage mapping was being applied in the left ventricle with a pentaray catheter, the nurse anesthetists noticed a drop-in the patient? S blood pressure followed by a loss of pulse. On the intracardiac echocardiography (ice), it was clear the heart was not adequately pumping blood. The medical intervention provided was shocks and compression, but nothing was successfully able to bring a pulse back and the patient expired. No bwi product malfunctions were reported. No effusion occurred during the case. No rf energy had been delivered. Physician? S opinion regarding the cause of the adverse event is that it was related to the patient? S prior condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00141 |
| MDR Report Key | 9624936 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-23 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-01-23 |
| 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 | PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER |
| Generic Name | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-01-23 |
| Catalog Number | UNK_PENTARAY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Death; 2. Required No Informationntervention | 2020-01-23 |