MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.
[33602009]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33602010]
It was reported that during implant a guidewire could not be removed from the patient because portions of the guidewire were stuck on the distal portion of the lead. Another guidewire was attempted and could only be introduced from the proximal to the distal end of the lead. The lead and guidewires were not used, another lead was successfully implanted with another guidewire. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[47401794]
Product event summary: the guidewire was returned, analyzed, and the guidewire was damaged. It was noted that the guidewire was unraveled. The analyst noted that there was minor damage to the coils. The tip was intact. There were stretched coils on the distal side of the distal bond and shifted coils on the proximal side of the distal bond joint 2cm from the tip. The proximal bond was intact. The wire outer diameter meets specification with the tip and bond joints not exceeding. 014?.
Patient Sequence No: 1, Text Type: N, H10
[101875092]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2015-00061 |
| MDR Report Key | 5280170 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2016-03-16 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2015-12-09 |
| 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 CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| 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 | 2015-12-09 |
| Returned To Mfg | 2015-10-01 |
| Model Number | LVZRXT180S |
| Catalog Number | LVZRXT180S |
| Lot Number | G14A08936 |
| Device Expiration Date | 2017-12-29 |
| 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 | 2015-12-09 |