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

Model Number	LVZRXT180J
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the full guidewire was returned in segments and analyzed.The analysis indicated that the guidewire was kinked/buckled.The guidewire was broken.The guidewire was unraveled.Visual analysis of the lead indicated damage during use.The analyst noted that the proximal portion of the guidewire was received in dispenser, and the distal portion was broke and stuck in lead.Visual inspection found the guidewire tip was kinked inside the lead tip nose.The visual inspection result leads us to conclude that during the procedure the guidewire was kinked.Kinked wire was obstructed by the lead conductor, and could not remove the guidewire from lead.The guidewire broke possible when force was applied.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, the guidewire became stuck inside the lead.The guidewire and lead were removed and a replacement lead was implanted.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: 8413003
• Report Number: 1220452-2019-00023
• Device Sequence Number: 389876
• Product Code: DQT
• UDI-Device Identifier: 00643169452299
• UDI-Public: 00643169452299
• 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): 03/12/2019

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: 04/24/2021
• Device Model Number: LVZRXT180J
• Device Catalogue Number: LVZRXT180J
• Device Lot Number: G18A04464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1