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 2020-03-23 for FLEXCATH ADVANCE STEERABLE SHEATH 4FC12 manufactured by Medtronic Cryocath Lp.
[184431122]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184431123]
It was reported that during a cryo ablation procedure, after the insertion of the sheath, a pericardial effusion was noticed. The case was aborted with the patient under general anesthesia. A pericardiocentesis was performed and the patient underwent surgery. The patient's hospital stay was extended. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00167 |
| MDR Report Key | 9864622 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 4FC12 |
| Catalog Number | 4FC12 |
| Lot Number | 0009980181 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-23 |