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

Model Number LVZRXT180J

Device Problems Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

It was reported that during the implant, after placing the lead in the target vein, the physician was using the support guidewire with the lead and when pulling the guidewire back, it got stuck in the vessel, which was very thin.With the retraction movement, the guidewire stretched and broke into two pieces; one part remained inside the lead and also out of the distal part of the lead, in the vein.The other piece was still in the physician's hand.The physician decided to leave the lead with the guidewire in place and removed the rest of the delivery system.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: some of the guidewire was returned and analyzed.The analysis indicated that the guidewire was unraveled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZINGER GUIDE WIRE - CRDM
• Type of Device: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 7090986
• MDR Text Key: 94494152
• Report Number: 1220452-2017-00126
• Device Sequence Number: 1
• Product Code: DQT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K983927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2018
• Device Model Number: LVZRXT180J
• Device Catalogue Number: LVZRXT180J
• Device Lot Number: G15A02720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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 Age: 75 YR