MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-13 for FLEXCATH ADVANCE STEERABLE SHEATH 4FC12 manufactured by Medtronic Cryocath Lp.
[188331457]
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. The overall baseline gender characteristics is male; the age of the patients was 70 years old. The baseline weight of the patients involved is 64 kgs. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: limited efficacy of a figure-of-eight suture for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants. J cardiol (2020), https://doi. Org/10. 1016/j. Jjcc. 2020. 01. 012. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188331458]
The literature publication reported the following patient complication during the use of a cryoballoon ablation catheter and sheath. There were two (2) patients who experienced pericardial effusions; however, no sign of cardiac tamponade was observed, and they did not require a pericardiocentesis. There were 31 patients with bleeding at the puncture site; out of this group there were two (2) patients with? Major? Bleeding. In addition, there were two (2) patients who had pseudoaneurysms; one required surgical intervention and a blood transfusion, and the other one was treated with manual compression and an injection of thrombin. These occurred at six and seven days after the procedure, respectively. Of note, multiple patients/methods/manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers. The status/location of the cryoballoon catheter and sheath is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00158 |
| MDR Report Key | 9831179 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | 4FC12 |
| Catalog Number | 4FC12 |
| 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 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-13 |