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 LVZRMS180J manufactured by Medtronic, Inc.
[82599973]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[82599974]
It was reported that during the implant procedure, while extracting the guidewire from the left ventricular (lv) lead, the physician felt abnormal resistance, which was not felt during lead placement over the guidewire. After the total retraction of the guidewire, it was observed the guidewire was frayed and damaged and with a "different aspect" when compared to the beginning. The guidewire and lv lead were replaced due to the physician's concern that the lv lead may have had particles in the lead lumen. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[102721735]
Product event summary: the partial guidewire was returned and analyzed, guidewire was broken. The stylet/guidewire was kinked/buckled. The guidewire was unraveled. Visual analysis of the lead indicated damage during use. The analyst noted that approximately 3cm of the distal end of guidewire was broken off and not returned. The guidewire could not be used for insertion test in returned lead. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2017-00074 |
| MDR Report Key | 6782247 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-09 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-08-17 |
| 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 |
| Returned To Mfg | 2017-06-02 |
| Model Number | LVZRMS180J |
| Catalog Number | LVZRMS180J |
| Lot Number | G15A06623 |
| 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 | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-09 |