MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for VIEWFLEX? XTRA ICE CATHETER D087031 manufactured by St. Jude Medical, Inc..
[187932359]
Investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[187932360]
Related manufacturer reference number: 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 3008452825-2020-00113, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred. After the procedure was completed, the patient became hypotensive, so an ultrasound was performed, confirming a pericardial effusion. A pericardiocentesis was performed to stabilize the patient. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030404-2020-00012 |
| MDR Report Key | 9744975 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-02-24 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | 2375 MORSE AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIEWFLEX? XTRA ICE CATHETER |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-25 |
| Model Number | D087031 |
| Catalog Number | D087031 |
| Lot Number | 7170475 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 2375 MORSE AVE IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |