MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.
[38331730]
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
[38331731]
It was reported that during use with left ventricular (lv) lead, the guide wire was destroyed. The guide wire was removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[42295227]
Product event summary: the device was returned and analyzed. Analysis revealed the stylet/guidewire was kinked/buckled, the guidewire was unraveled.
Patient Sequence No: 1, Text Type: N, H10
[47405768]
Product event summary: additional analysis of the returned guidewire noted damage during use. Analysis revealed the stylet/guidewire was broken, the stylet/guidewire was kinked/buckled, the guidewire was unraveled. Additional analysis of the returned guide wire noted one lv zinger guide wire with no original packaging. As received the wire was coil wrapped in a pouch. The wire is stretched and missing the distal tip. From the proximal end of the wire to the distal end of the core wire measures approximately 176cm indicating approximately 2cm of the wire is missing including the distal bond joint, solder tip and ribbon. The blood was cleaned from end of wire with warm water. The broke end of the coil is visible. The break occurred on the proximal side of the distal bond joint. Proximal bond shows coil stretched in a distal direction. It appears the wire was torqued beyond the design requirements. No manufacturing root cause identified. The detached tip of the wire was not returned.
Patient Sequence No: 1, Text Type: N, H10
[101875925]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2016-00004 |
| MDR Report Key | 5422059 |
| Date Received | 2016-02-09 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2015-01-12 |
| Date Added to Maude | 2016-02-09 |
| 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 | 2016-02-09 |
| Returned To Mfg | 2015-12-22 |
| Model Number | LVZRXT180S |
| Catalog Number | LVZRXT180S |
| Lot Number | G15A00318 |
| Device Expiration Date | 2018-01-11 |
| 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 | 2016-02-09 |