MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for BIOSENSE WEBSTER PENTARAY NAV D128211 manufactured by Biosense Webster, Inc..
[176020108]
During ep cryo-ablation case, 3d map of biosense webster pentaray catheter was no longer visible and usable. Physician tried to replace pentaray cath to rebuild 3d map but to no avail. Case had to be abandoned without successful intervention. Physician reported he has encountered such intermittent issues in the past with the pentaray catheter. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092335 |
| MDR Report Key | 9601537 |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-19 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSENSE WEBSTER PENTARAY NAV |
| Generic Name | CATHETER, INTRACARDIAL MAPPING HIGH DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-01-16 |
| Catalog Number | D128211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSENSE WEBSTER, INC. |
| Manufacturer Address | IRWINDALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-16 |