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

Model Number	LVZRXT180J
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure after the left ventricular (lv) lead was placed in the vein, the guidewire was att empted to be removed, but it was peeled and broke with a part remaining inside the lead with the distal portion of it out and inside the vein of the coronary sinus.It was only possible to remove one portion of the guidewire at first, while the other portion of the wire was still inside the lead in the vein.Pulling the thread left to peel, the physician managed to remove all of the guidewire without further trouble.It was noted that the guidewire coating was separated from the wire.No patient complications have been reported as a result of this event.

• Brand Name: ZINGER GUIDE WIRE - CRDM
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6782492
• Report Number: 1220452-2017-00075
• Device Sequence Number: 16528702
• Product Code: DQT
• UDI-Device Identifier: 20643169452293
• UDI-Public: 20643169452293
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: LVZRXT180J
• Device Catalogue Number: LVZRXT180J
• Device Lot Number: G16A02434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1