MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2013-08-09 for ZINGER LIGHT LVZRLS180S manufactured by Rice Creek Mfg.
[15778131]
It was reported that during the implant procedure, the guidewire could not be retracted. On fluoroscopy, the image shows a "curled tip" of the guidewire. The guidewire was suspected to be fractured at the tip. The physician was unable to put traction force on it without risking the guidewire to break off at the tip and leave part in the heart. The physician was also unable to reposition the left ventricular (lv) lead at this point without damage. It was tried to remove lead and guidewire as a unit, but this was not possible as a small distal part of the wire remained stuck in the venous structure while part of the wire remained attached as well to the distal part of the lead. It was then decided by the physician to leave both guidewire and lv lead implanted in the patient. Patient is part of the (b)(6) study. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15872747]
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
| Report Number | 2182208-2013-02042 |
| MDR Report Key | 3275130 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-08-09 |
| Date of Report | 2013-05-06 |
| Date of Event | 2013-05-06 |
| Date Mfgr Received | 2013-05-06 |
| Date Added to Maude | 2013-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| 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 LIGHT |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2013-08-09 |
| Model Number | LVZRLS180S |
| Catalog Number | LVZRLS180S |
| Lot Number | 60293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-09 |