MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-03 for PENTARAY NAV ECO 7FR, F, 2-6-2 D128208 manufactured by Biosense Webster Inc.
[188860486]
The product was discarded. Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed. A manufacturing record evaluation was performed for the finished device and no internal actions were identified. No code available was used to represent 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
[188860487]
It was reported that a (b)(6) year old female patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter, and a medical device entrapment issue occurred requiring surgical intervention. One of the splines for the pentaray catheter became entrapped in the patient's prosthetic mitral valve. The physician was advised that use of the pentaray catheter in patients with prosthetic valves contradicts the instructions for use. The physician was attempting to free the catheter from the valve at the time of the call. Patient had to have open heart surgery. Surgery was successful to remove penta ray and the patient was reported in stable condition. There was no patient consequence. The physician? S opinion on the cause of this event is that it was due to the patient having a mechanical valve. The observed medical device entrapment requiring surgical intervention, has been assessed as mdr reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00006 |
| MDR Report Key | 9545202 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-01-03 |
| 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 ECO 7FR, F, 2-6-2 |
| Generic Name | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-01-03 |
| Catalog Number | D128208 |
| Lot Number | 30289201L |
| 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. Required No Informationntervention | 2020-01-03 |