MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for ZINGER GUIDE WIRE - CRDM LVZRMS180J manufactured by Medtronic, Inc.
[82591617]
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
[82591618]
It was reported that during the implant procedure, the guidewire became stuck and then shredded while in the left ventricular (lv) lead. The physician was able to pull the guidewire out, however, it was falling apart. The guidewire was replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[106600152]
Product analysis: the received guidewire was received badly damaged and stretched. The distal end of the guidewire was stretched resulting in the core wire separating from the distal bond 2cm from the tip. The distal 2 cm with tip was still attached by the stretched coil wire. The distal tip meets specification (. 014? Max) at. 0134?. Measurement from the proximal bond to the end of the core wire is approx. 27. 5cm indicating the core wire pulled apart at the distal bond and is all accounted for. At the end of the stretched coil wire was the distal bond, ribbon and solder tip. Ribbon is intact, close inspection of the distal bond shows evidence of bonding of the core wire and evidence that the core wire did not pull out of the bond but broke (pull force) at the bond. None of the wire is missing, no missing components. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2017-00072 |
| MDR Report Key | 6779491 |
| Date Received | 2017-08-09 |
| Date of Report | 2018-04-25 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2015-06-06 |
| 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 | 0 |
| Brand Name | ZINGER GUIDE WIRE - CRDM |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2017-08-09 |
| Returned To Mfg | 2017-06-08 |
| Model Number | LVZRMS180J |
| Catalog Number | LVZRMS180J |
| Lot Number | G15A05770 |
| Device Expiration Date | 2018-06-05 |
| 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 |