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 2019-03-12 for ZINGER GUIDE WIRE - CRDM LVZRMS180J manufactured by Medtronic, Inc.
[138548252]
Product event summary: the guidewire was returned and analyzed. The analysis indicated that the guidewire was damaged. The guidewire was kinked/buckled. The guidewire was unraveled. Visual analysis of the lead indicated damage during use. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138548253]
It was reported that during implant, the guidewire became stuck inside the lead and was unable to be retracted. The physician removed both the lead and guidewire and implant was attempted with a new lead as well as a new guidewire. During implant of the replacement lead, the new guidewire again became stuck in the lead, however the guidewire was eventually able to be retracted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2019-00022 |
| MDR Report Key | 8412741 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2015-06-04 |
| Date Added to Maude | 2019-03-12 |
| 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 | LISA ROBERTSON |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262723 |
| 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 | 2019-03-12 |
| Returned To Mfg | 2018-01-19 |
| Model Number | LVZRMS180J |
| Catalog Number | LVZRMS180J |
| Lot Number | G15A05727 |
| Device Expiration Date | 2018-06-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-12 |