MAUDE Adverse Event Report: MEDTRONIC, INC. ZINGER GUIDE WIRE - CRDM; WIRE, GUIDE, CATHETER

Model Number LVZRXT180S

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 02/12/2014

Event Type  Injury  

Event Description

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try and position the lead into the coronary sinus vein.The second attempt was unsuccessful; subsequently, the lead was withdrawn and then the guidewire.As the guidewire exited the guide catheter, the physician noted the wire had become stripped and a small thin strand of wire remained in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.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: ZINGER GUIDE WIRE - CRDM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3744713
• MDR Text Key: 4225670
• Report Number: 2182208-2014-01095
• Device Sequence Number: 1
• Product Code: DQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LVZRXT180S
• Device Catalogue Number: LVZRXT180S
• Device Lot Number: GS657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00059 YR