MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for ARCTIC FRONT ADVANCE? CARDIAC CRYOABLATION CATHETER 2AF283 manufactured by Medtronic Cryocath Lp.
[183705294]
Product event summary: the data files and balloon catheter, 2af283 with lot 80437, were returned and analyzed. The returned files showed multiple system notices 50005,? The safety system has detected fluid in the catheter and stopped the injection? Was triggered multiple times on the date of the event. Visual inspection of catheter showed the device was intact with no apparent issues. Smart chip verification indicated the catheter was used for six injections. The catheter failed performance test due to system notice 50005, indicating that the safety system detected fluid in the catheter and stopped the injection. The dissection test revealed a guide wire lumen kink and breach at 1. 28 inches from the tip. In conclusion, the balloon catheter failed inspection due to a guide wire lumen kink and breach. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183705295]
The balloon catheter subsequently tested out of specification per the manufacturer's investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002648230-2020-00153 |
| MDR Report Key | 9828874 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-31 |
| 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 | ARCTIC FRONT ADVANCE? CARDIAC CRYOABLATION CATHETER |
| Generic Name | PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OAE |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 2AF283 |
| Catalog Number | 2AF283 |
| Lot Number | 80437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-13 |