MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-05 for ACHIEVE MAPPING CATHETER - 15 MM 990063-015 manufactured by Medtronic Cryocath Lp.
[188331028]
Concomitant medical products: arctic front advance cardiac cryoablation catheter 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. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old. 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:? Left atrial volume index predicts arrhythmia-free survival in patients with persistent atrial fibrillation undergoing cryoballoon ablation.? Journal of atrial fibrillation. 2019; 12(2). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188331029]
The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system. There were three (3) patients experienced phrenic nerve palsy (pnp) which lasted beyond the end of the procedure; however, all of which completely resolved within six months. There was one (1) patient who developed a hematoma, and one (1) patient had a femoral pseudoaneurysm; for both patients, there was no indication of treatment/resolution. The status/location of the system 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 | 3002648230-2020-00143 |
| MDR Report Key | 9793337 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-05 |
| 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 | ACHIEVE MAPPING CATHETER - 15 MM |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-05 |
| Model Number | 990063-015 |
| Catalog Number | 990063-015 |
| 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. Required No Informationntervention | 2020-03-05 |