MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER MEDIUM; OCCLUDER, CATHETER TIP

Model Number	LVZRMS180S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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 delivery system withdrawal, a piece of the guidewire was left between the right ventricle and the superior vena cava (svc).The segment was removed with a snare.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was received in two pieces: the distal portion measuring approximately 33cm and the proximal portion measuring approximately 149cm.The wire was badly damaged, kinked, stretched, and the core wire was broken in two locations, 32cm & 33cm from the distal tip of the wire.No parts of the wire are missing.The full length is accounted for.The distal tip is intact.The distal bond intact coils are stretched.The distal end of the break shows an acute kink and necking indicating pull (tensile) force.The proximal end of the break also indicates an acute kink.The two pieces clearly show the wire was kinked and possibly torqued or pulled to break point.There is a second kink and stretched coils 1cm from the initial break in the core wire.When the coils were pulled back to expose the core wire, it was revealed the core wire is broke at this second location also at an acute kink.The damage seen in the returned wire does not indicate a manufacturing- related defect but handling beyond design expectation.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 MEDIUM
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7655392
• Report Number: 1220452-2018-00083
• Device Sequence Number: 13492554
• Product Code: DQT
• UDI-Device Identifier: 00643169452305
• UDI-Public: 00643169452305
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/25/2019

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: 07/29/2018
• Device Model Number: LVZRMS180S
• Device Catalogue Number: LVZRMS180S
• Device Lot Number: G15A07081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 01/25/2019
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 10/01/2018; 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1