MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for ARCTIC FRONT ADVANCE PRO? CARDIAC CRYOABLATION CATHETER AFAPRO28 manufactured by Medtronic Cryocath Lp.
[187628408]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187628409]
It was reported that during a cryo ablation procedure, a slight effusion and tamponade were observed after transeptal puncture with a competitor's needle. A slight drop in blood pressure was observed. The procedure continued; however, the effusion grew and the blood pressure continued to decrease. Drainage was performed and the procedure was aborted. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00184 |
| MDR Report Key | 9899192 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-30 |
| 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 | ARCTIC FRONT ADVANCE PRO? CARDIAC CRYOABLATION CATHETER |
| Generic Name | PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OAE |
| Date Received | 2020-03-30 |
| Model Number | AFAPRO28 |
| Catalog Number | AFAPRO28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-30 |