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 2020-03-27 for THERMOCOOL? SF NAV BI-DIRECTIONAL CATHETER BNI35DFH manufactured by Biosense Webster Inc..
[185478946]
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed. A manufacturing record evaluation (mre) cannot be conducted because no lot/serial number was provided by the customer. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(6). (b)(4). Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: for product code bni35dfh (thermocool? Smart touch? Sf bi-directional navigation catheter). Mfr # 2029046-2020-00489 for product code m4900107 (smartablate? System rf generator).
Patient Sequence No: 1, Text Type: N, H10
[185478947]
It was reported that a female patient underwent repeat persistent atrial fibrillation (afib) ablation procedure with a thermocool? Sf nav bi-directional catheter and a smartablate? System rf generator and suffered atrioesophageal fistula and air embolism requiring hospitalization and death. A female patient born in (b)(6) underwent a repeat pulmonary vein isolation (pvi) using thermocool? Sf nav bi-directional catheter and lasso? Nav eco variable catheter without any problems. The patient was sent home after uncomplicated procedure without any known side effects. Patient was hospitalized approx. 2 weeks after the procedure in another hospital due to breast pain and malaise. A computed tomography (ct) scan didn? T show any conspicuousness. During that time the patient? S condition deteriorated showed signs of worsening outcome. Gastroscopy revealed atria-esophageal fistula in patient. The patient developed air embolism and fistula was treated with clips. Pressure chamber treatment was performed. Patient was in intensive care at the moment of the call in very serious condition with dire prognosis and subsequently expired. The physician? S opinion on the cause of this adverse event is that it was procedure related. During the procedure the visitag module was used with unknown stability parameters and total time for color option. No additional visitag filters were used. The smartablate? System rf generator was set to power control mode with default settings for thermocool? Sf catheters. There was no perforation suspected during procedure. No error messages were observed on biosense webster equipment during the procedure. To prevent esophageal injury low power (25w), low duration in ablation (30s maximum duration) was used. Based on the event details a strong argument can be made that the air embolism did not occur during the procedure but rather was a cascade of harms from the atrioesophageal fistula. Therefore, air embolism will only be conservatively coded only under the thermocool? Sf nav bi-directional catheter only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00488 |
| MDR Report Key | 9891850 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-27 |
| 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 | THERMOCOOL? SF NAV BI-DIRECTIONAL CATHETER |
| Generic Name | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Product Code | LPB |
| Date Received | 2020-03-27 |
| Model Number | BNI35DFH |
| Catalog Number | BNI35DFH |
| 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. Death; 2. Hospitalization | 2020-03-27 |