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

Model Number	LVZRXT180J
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the guidewire was unraveled.The guidewire was damaged.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during placement of the left ventricular (lv) lead, the zinger wire broke off inside the lead body when removing the wire.It was noted that the distal end of the wire was in the lead and coming out of the end of the lead.The lead and wire were not used and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.Visual analysis of the lead indicated the wire is stretched and pulled apart at the distal end and missing the tip.As received the distal end of the wire is missing the distal 2 centimeters including tip and distal bond joint.The end of the core wire is curled and is kinked in several places.The wire is stretched from the proximal bond forward approximately 27 centimeters.If information is provided in the future, a supplemental report will be issued.

• 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: 8386776
• Report Number: 1220452-2019-00018
• Device Sequence Number: 2030227
• Product Code: DQT
• UDI-Device Identifier: 20643169452293
• UDI-Public: 20643169452293
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 08/14/2020
• Device Model Number: LVZRXT180J
• Device Catalogue Number: LVZRXT180J
• Device Lot Number: G17A05051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR