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 2020-03-11 for FLEXCATH ADVANCE STEERABLE SHEATH 4FC12 manufactured by Medtronic Cryocath Lp.
[183008968]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183008969]
It was reported that post-operative to a successful cryo ablation procedure, the patient experienced "pericardial pain". The patient was treated with medication. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00151 |
| MDR Report Key | 9819546 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Model Number | 4FC12 |
| Catalog Number | 4FC12 |
| Lot Number | 92044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2 | 1. Required No Informationntervention | 2020-03-11 |