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 2020-03-19 for CORONARY SINUS CATHETER CRYO-UNKNOWN manufactured by Medtronic Cryocath Lp.
[188331930]
Concomitant medical products: competitor laa occlusion device procedure. 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 manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/manufacturers. The overall baseline gender characteristics is 50% male and 50% female; the age of the patients was 65 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 appendage management with the watchman device during hybrid ablation of atrial fibrillation.? Hindawi journal of interventional cardiology. Volume 2019, article id 4525084, 7 pages. Https://doi. Org/10. 1155/2019/4525084. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188331931]
The literature publication reported the following patient complications during the use of a coronary sinus catheter. Of note, the complications that occurred were? Not necessarily related to the device implantation.? There was one patient who experienced a pneumothorax, which was drained with a pleural catheter; one patient with transient elevated right hemidiaphragm; one patient with pericarditis; one hospital admission because of tachycardiomyopathy; one patient who needed a blood transfusion two days after the procedure, due to? Excessive blood? Loss through the thoracic drain, which occurred on the date of the procedure; for this patient medication given and the bleeding stopped. Of note, multiple patients/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 catheter 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 | 3002648230-2020-00164 |
| MDR Report Key | 9856868 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-19 |
| 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 | CORONARY SINUS CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-19 |
| Model Number | CRYO-UNKNOWN |
| Catalog Number | CRYO-UNKNOWN |
| 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. Life Threatening; 3. Required No Informationntervention | 2020-03-19 |