MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-11 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc..
[4225670]
It was reported that during the implant procedure, the guidewire was used to position the lead in the coronary sinus vein. There was difficulty positioning the guide catheter so a venoplasty was performed using the guidewire as a rail over which the venoplasty balloon was advanced. The guidewire was also used to try and position the lead over the wire to the selected vein. This attempt was not successful and a second venoplasty was performed. The same technique was used again to try and position the lead into the coronary sinus vein. The second attempt was unsuccessful; subsequently, the lead was withdrawn and then the guidewire. As the guidewire exited the guide catheter, the physician noted the wire had become stripped and a small thin strand of wire remained in the coronary vein. Attempts to remove the wire with a snare were unsuccessful. When the sheath with the strand was removed, the guidewire remanent remained visible in the coronary vein. The patient sustained an air embolus that resulted in circulatory and respiratory collapse requiring resuscitation and intubation. At the end of the procedure, the patient was on ventilatory support and an intravenous pressors infusion. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11735991]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2014-01095 |
| MDR Report Key | 3744713 |
| Report Source | 05,07 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-02-12 |
| Date Mfgr Received | 2014-02-12 |
| Date Added to Maude | 2014-04-15 |
| 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 GUIDE WIRE - CRDM |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQT |
| Date Received | 2014-04-11 |
| Model Number | LVZRXT180S |
| Catalog Number | LVZRXT180S |
| Lot Number | GS657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2014-04-11 |