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 2017-08-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180J manufactured by Medtronic, Inc.
[82674852]
Patient Sequence No: 1, Text Type: N, H10
[82674853]
It was reported that during the implant procedure after the left ventricular (lv) lead was placed in the vein, the guidewire was att empted to be removed, but it was peeled and broke with a part remaining inside the lead with the distal portion of it out and inside the vein of the coronary sinus. It was only possible to remove one portion of the guidewire at first, while the other portion of the wire was still inside the lead in the vein. Pulling the thread left to peel, the physician managed to remove all of the guidewire without further trouble. It was noted that the guidewire coating was separated from the wire. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2017-00075 |
| MDR Report Key | 6782492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-09 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2016-03-28 |
| Date Added to Maude | 2017-08-09 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZINGER GUIDE WIRE - CRDM |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2017-08-09 |
| Model Number | LVZRXT180J |
| Catalog Number | LVZRXT180J |
| Lot Number | G16A02434 |
| Device Expiration Date | 2019-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-09 |