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

Model Number	LVZRMS180J
Medical Device Problem Codes	Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 and then shredded while in the left ventricular (lv) lead.The physician was able to pull the guidewire out, however, it was falling apart.The guidewire was replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the received guidewire was received badly damaged and stretched.The distal end of the guidewire was stretched resulting in the core wire separating from the distal bond 2cm from the tip.The distal 2 cm with tip was still attached by the stretched coil wire.The distal tip meets specification (.014¿ max) at.0134¿.Measurement from the proximal bond to the end of the core wire is approx.27.5cm indicating the core wire pulled apart at the distal bond and is all accounted for.At the end of the stretched coil wire was the distal bond, ribbon and solder tip.Ribbon is intact, close inspection of the distal bond shows evidence of bonding of the core wire and evidence that the core wire did not pull out of the bond but broke (pull force) at the bond.None of the wire is missing, no missing components.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: 6779491
• Report Number: 1220452-2017-00072
• Device Sequence Number: 131978
• Product Code: DQT
• UDI-Device Identifier: 20643169452316
• UDI-Public: 20643169452316
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/25/2018

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: 06/05/2018
• Device Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G15A05770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR