MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-09 for ATTAIN VENOGRAM BALLOON CATHETER 6215 manufactured by Medtronic, Inc..
[161919596]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[161919597]
It was reported that the during the implant attempt of the left ventricular (lv) lead, a balloon catheter was used to visualize the coronary veins. Four balloon inflations were done. On the fifth attempt to inflate the balloon, it would not inflate under fluoroscopy. The catheter was removed from the patient and the balloon still could not be inflated. A rupture of the balloon was suspected. The catheter was replaced with a new one to complete the procedure. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[166073691]
Concomitant medical products: the balloon catheter was returned and analyzed. The analysis indicated that the balloon was ruptured. The mechanical operation of the balloon catheter had leaks and/or was incontinent. Visual analysis of the balloon catheter indicated damage during use. The analyst noted the balloon catheter was returned without the inflation syringe. There was contrast on the infusion port and there was blood on the balloon at the distal end of the balloon catheter. There was blood and contrast at the distal orifice and a hole in the balloon at 0. 5 cm from the distal end of the balloon catheter. The balloon would not stay inflated with air injected into the balloon. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-04282 |
| MDR Report Key | 9172867 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-09 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2019-04-26 |
| Date Added to Maude | 2019-10-09 |
| 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, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTAIN VENOGRAM BALLOON CATHETER |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2019-10-09 |
| Returned To Mfg | 2019-10-09 |
| Model Number | 6215 |
| Catalog Number | 6215 |
| Lot Number | 0061660449 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-09 |