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

Model Number	LVZRMS180J
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
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, while extracting the guidewire from the left ventricular (lv) lead, the physician felt abnormal resistance, which was not felt during lead placement over the guidewire.After the total retraction of the guidewire, it was observed the guidewire was frayed and damaged and with a "different aspect" when compared to the beginning.The guidewire and lv lead were replaced due to the physician's concern that the lv lead may have had particles in the lead lumen.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the partial guidewire was returned and analyzed, guidewire was broken.The stylet/guidewire was kinked/buckled.The guidewire was unraveled.Visual analysis of the lead indicated damage during use.The analyst noted that approximately 3cm of the distal end of guidewire was broken off and not returned.The guidewire could not be used for insertion test in returned lead.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: 6782247
• Report Number: 1220452-2017-00074
• Device Sequence Number: 920018
• Product Code: DQT
• UDI-Device Identifier: 20643169452316
• UDI-Public: 20643169452316
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 05/22/2017

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 Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G15A06623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR