MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-01 for ZINGER GUIDE WIRE - CRDM LVZRMS180J manufactured by Medtronic, Inc.
[107008526]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107008527]
It was reported that during the implant procedure, the guidewire unraveled. The physician stated there was never any sticking of the guidewire in the left ventricular (lv) lead and the physician pulled back the guidewire and the wire had fallen apart with many thin wispy like pieces everywhere. The distal portion of the wire was still externalized at the lead tip and came back with the lead both times. The lead and the guidewire were removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[107444041]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118544777]
Product event summary: the guidewire was returned and engaged in the lead. The distal tip of the wire was still attached by the coil and the wire was stretched from the proximal bond joint forward. The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint; the wire was badly damage. There was a kink in the distal tip behind the solder joint. Distal end of broke core wire. There appeared to be a surface imperfection at the break site and the proximal bond joint was stretched indicating pull force. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118545077]
Product event summary: the wire was engaged in the lead. The distal tip of the wire was still attached by the coil. The wire was stretched from the proximal bond joint forward. The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint. The wire was damaged. None of the wire was missing and the distal tip of wire was s shaped. There was a kink in the distal tip behind the solder joint. Distal end of broke core wire. There appeared to be a surface imperfection at the break site. The proximal bond joint was stretched indicating pull force. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2018-00040 |
| MDR Report Key | 7476406 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-01 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2018-05-01 |
| 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 | 2018-05-01 |
| Returned To Mfg | 2018-04-20 |
| Model Number | LVZRMS180J |
| Catalog Number | LVZRMS180J |
| Lot Number | G15A07657 |
| Device Expiration Date | 2018-08-25 |
| 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 | 4298 | 1. Life Threatening | 2018-05-01 |