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 2019-10-23 for PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER D128211 manufactured by Biosense Webster Inc.
[163954654]
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. We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental. No code available was used to represent the required surgical intervention. 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
[163954655]
It was reported that on (b)(6) 2019 a patient with a known prosthetic mitral valve underwent an maze technique atrial tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter, and an entrapment issue occurred requiring surgical intervention. The catheter was removed but one spline remained stuck in the valve and was removed using a snare tool. The removed catheter had an exposed wire. The procedure was completed without patient consequence. The pentaray nav eco catheter instructions for use states? Do not use pentaray? Catheters in patients with prosthetic valves.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2019-03789 |
| MDR Report Key | 9224612 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-23 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-09-25 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2019-06-06 |
| Date Added to Maude | 2019-10-23 |
| 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 | 2019-10-23 |
| Catalog Number | D128211 |
| Lot Number | 30235455L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-10-23 |