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

Model Number	LVZRMS180J
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
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 unraveled.The physician stated there was never any sticking of the guidewire in the left ventricular (lv) lead and the physician pulled back the guidewire and the wire had fallen apart with many thin wispy like pieces everywhere.The distal portion of the wire was still externalized at the lead tip and came back with the lead both times.The lead and the guidewire were removed and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and engaged in the lead.The distal tip of the wire was still attached by the coil and the wire was stretched from the proximal bond joint forward.The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint; the wire was badly damage.There was a kink in the distal tip behind the solder joint.Distal end of broke core wire.There appeared to be a surface imperfection at the break site and the proximal bond joint was stretched indicating pull force.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the wire was engaged in the lead.The distal tip of the wire was still attached by the coil.The wire was stretched from the proximal bond joint forward.The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint.The wire was damaged.None of the wire was missing and the distal tip of wire was s shaped.There was a kink in the distal tip behind the solder joint.Distal end of broke core wire.There appeared to be a surface imperfection at the break site.The proximal bond joint was stretched indicating pull force.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7476406
• Report Number: 1220452-2018-00040
• Device Sequence Number: 16631659
• Product Code: DQT
• UDI-Device Identifier: 20643169452316
• UDI-Public: 20643169452316
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/02/2018

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: 08/25/2018
• Device Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G15A07657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018; 08/07/2018; 08/23/2018; 08/08/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/03/2018; 08/08/2018; 08/28/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4298-88 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 88 YR