MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for THERMOCOOL? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETER D134805 manufactured by Biosense Webster Inc.
| Report Number | 2029046-2020-00501 |
| MDR Report Key | 9900642 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-10-18 |
| Date Added to Maude | 2020-03-30 |
| 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? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETER |
| Generic Name | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Product Code | LPB |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-23 |
| Model Number | D134805 |
| Catalog Number | D134805 |
| Lot Number | 30303887M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-03-30 |