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 2018-07-02 for ZINGER MEDIUM LVZRMS180S manufactured by Medtronic, Inc.
[113179469]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[113179490]
It was reported that during delivery system withdrawal, a piece of the guidewire was left between the right ventricle and the superior vena cava (svc). The segment was removed with a snare. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1220452-2018-00083 |
MDR Report Key | 7655392 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2018-07-02 |
Date of Report | 2019-01-25 |
Date of Event | 2018-06-25 |
Date Mfgr Received | 2019-01-25 |
Device Manufacturer Date | 2015-07-30 |
Date Added to Maude | 2018-07-02 |
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 MEDIUM |
Generic Name | OCCLUDER, CATHETER TIP |
Product Code | DQT |
Date Received | 2018-07-02 |
Returned To Mfg | 2018-07-09 |
Model Number | LVZRMS180S |
Catalog Number | LVZRMS180S |
Lot Number | G15A07081 |
Device Expiration Date | 2018-07-29 |
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 | 2018-07-02 |