MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	ZNGRS180HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Occlusion (1984); ST Segment Elevation (2059); Thrombus (2101); Patient Problem/Medical Problem (2688); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
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
The target lesion was in the rca.No damage was noted to packaging of a zinger guidewire.No issues were noted to the device when removing from the packaging.The device was inspected and prepped per ifu with no issues noted.3 non-medtronic stents were implanted.The physician placed the wire and delivered the 3 non-medtronic stents.When removing the wire the zinger got caught on middle stent and the middle stent became deformed.Patient started having symptoms and was taken to surgery.It is reported that the zinger wire detached in the patient.Vessel occlusion occurred due to device component.There was vessel damage/injury.The detached portion was trapped in the patient.The physician does not believe the event was due to the wire.The physician thinks it was user error, that perhaps the wire was placed too deep.It is reported that the patient is ok.
Additional Manufacturer Narrative
Image review: images exhibit the stated case of a piece of the wire broken and trapped/stuck in the stent struts.Evaluation summary: the wire was broken at the distal tip.The returned portion of the wire measured 177.5cm.The wire exhibited bunched up coils 1-4cm from the distal joint due to possible twisting or torquing it during use, the breakage was noted near the distal tip with severely stretched coils at the break.The broken piece as reported remained in the patient.Approximately 2.5cm of the distal wire was missing from the manufactured wire full length of 180cm.Wire outer diameter during measurements passed od requirements and not a contributor to the wire breaking during use.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
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6559550
• Report Number: 1220452-2017-00039
• Device Sequence Number: 16416311
• Product Code: DQX
• UDI-Device Identifier: 20643169452576
• UDI-Public: 20643169452576
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2018
• Device Model Number: ZNGRS180HS
• Device Catalogue Number: ZNGRS180HS
• Device Lot Number: G15A10938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 06/08/2017; 06/08/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/07/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention