MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-16 for UNK_PENTARAY manufactured by Biosense Webster Inc.
[183550278]
(b)(4). 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. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[183550279]
This complaint is from a literature source. As reported in the literature publication entitled,? Focal ventricular tachycardias in structural heart disease prevalence, characteristics, and clinical outcomes after catheter ablation.? 1 patient with structural heart disease (shd) who have focal ventricular tachycardia (vt) who underwent undergoing vt ablation died within 30 days after readmission with multiorgan dysfunction without recurrent vas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00418 |
| MDR Report Key | 9835808 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-16 |
| 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 | UNK_PENTARAY |
| Generic Name | CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE |
| Product Code | MTD |
| Date Received | 2020-03-16 |
| Catalog Number | UNK_PENTARAY |
| 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 | 2020-03-16 |