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

Model Number	LVZRXT180S
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 to the tip of the left ventricular (lv) lead.The lv lead and guidewire were 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.Analysis indicated that the guidewire was kinked/buckled.The stylet/guidewire was broken.The guidewire was unraveled.Visual analysis of the lead indicated damage during use.The analyst noted that the visual inspection results lead us to conclude that during the procedure guidewire kink was occurred.Kinked wire was obstructed by the lead conductor and could not remove the guidewire from lead.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 to the tip of the left ventricular (lv) lead.The lv lead and guidewire were replaced.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: 7820152
• Report Number: 1220452-2018-00105
• Device Sequence Number: 2335836
• Product Code: DQT
• UDI-Device Identifier: 00643169452282
• UDI-Public: 00643169452282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• 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: 09/20/2018
• Device Model Number: LVZRXT180S
• Device Catalogue Number: LVZRXT180S
• Device Lot Number: G15A08517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 08/27/2018
• Supplement 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