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.
[188859595]
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. 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
[188859596]
It was reported that a patient underwent an ablation procedure for left sided atrial flutter (l-afl) with a pentaray nav high-density mapping eco catheter, and medical device entrapment and foreign body in patient issues occurred. Two of the electrodes came off the catheter. The electrodes were caught on a mechanical valve and were left inside the patient. The pentaray nav high-density mapping eco catheter instructions for use list use of the pentaray in prosthetic valve as a contraindication. The observed device entrapment and foreign body in patient issues have been assessed as mdr reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00009 |
| MDR Report Key | 9548470 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-09-10 |
| 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 | 30291385L |
| 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 | 2020-01-03 |