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 2020-03-25 for FLEXCATH ADVANCE STEERABLE SHEATH 4FC12 manufactured by Medtronic Cryocath Lp.
[184892702]
Concomitant medical products: 2af284 balloon catheter product event summary: the data files were returned and analyzed. The data files showed that 16 applications were performed with balloon catheter, 2af284 with lot number 00329, without any issue on the date of the event. Clinical issues were encountered during the procedure. There is no indication of relation of adverse event to the performance and malfunction of the product. The physical product was not returned for investigation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184892703]
It was reported that after a successful cryo ablation procedure, pericardial effusion was evident through intracardiac echocardiography (ice) imaging. Measures were taken to optimize blood pressure and heart rate. Pericardiocentesis, open chest procedure, cardiopulmonary resuscitation (cpr), and blood transfusions were performed. The patient is deceased. The cause of death was cardiac tamponade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00173 |
| MDR Report Key | 9879087 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-04-15 |
| Date Added to Maude | 2020-03-25 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC CRYOCATH LP |
| Manufacturer Street | 9000 AUTOROUTE TRANSCANADIENNE |
| Manufacturer City | POINTE-CLAIRE,QC H9R 5Z8 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H9R 5Z8 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXCATH ADVANCE STEERABLE SHEATH |
| Generic Name | CATHETER, STEERABLE |
| Product Code | DRA |
| Date Received | 2020-03-25 |
| Model Number | 4FC12 |
| Catalog Number | 4FC12 |
| Lot Number | 85414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC CRYOCATH LP |
| Manufacturer Address | 9000 AUTOROUTE TRANSCANADIENNE POINTE-CLAIRE,QC H9R 5Z8 CA H9R 5Z8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 990063 | 1. Death | 2020-03-25 |