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 LVZRXT180J manufactured by Medtronic, Inc.
[138568077]
Product event summary: the full guidewire was returned in segments and analyzed. The analysis indicated that the guidewire was kinked/buckled. The guidewire was broken. The guidewire was unraveled. Visual analysis of the lead indicated damage during use. The analyst noted that the proximal portion of the guidewire was received in dispenser, and the distal portion was broke and stuck in lead. Visual inspection found the guidewire tip was kinked inside the lead tip nose. The visual inspection result leads us to conclude that during the procedure the guidewire was kinked. Kinked wire was obstructed by the lead conductor, and could not remove the guidewire from lead. The guidewire broke possible when force was applied. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138568078]
It was reported that during the implant procedure, the guidewire became stuck inside the lead. The guidewire and lead were removed and a replacement lead was implanted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2019-00023 |
| MDR Report Key | 8413003 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-04-25 |
| 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 | 2018-07-09 |
| Model Number | LVZRXT180J |
| Catalog Number | LVZRXT180J |
| Lot Number | G18A04464 |
| 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 |