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

Catalog Number	ZNGRMS180S
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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
A zinger guidewire was being used to treat a lesion in the distal left anterior descending artery (lad).The lesion was reported to be mildly tortuous, moderately calcified and exhibiting 75% stenosis.No abnormalities were reported in relation to the anatomy.No damage was noted to the packaging, no issues were noted to the device when removing from the packaging per the ifu.The device was inspected and prepped per the ifu with no issues noted.The wire tip was formed by the physician.The lesion was not pre-dilated.The device passed through a previously deployed stent.Resistance was encountered however excessive force was not used.It was reported that the device appeared to unravel or become stretched upon removal from the patient.The wire appeared stretched and did not retain its shape.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
The shaping of the wire tip was done with a metal instrument.It was indicated that the coating appeared to come off the wire, from the tip going back about 10cm.No portion of the wire remains in the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: one zinger guidewire was received for analysis.As received the wire was severely unraveled and exhibited stretched coils which were entangled together.The core wire was pulled out from the 1st joint and remained attached to the proximal joint.The coils at the proximal joint were stretched.The od of the proximal joint met specification at 0.0134¿.The 1st joint was intact, and the od measured 0.0134¿ meeting specification.Although the wire was severely kinked and bent, the distal tip ball was intact.The wire is not coated at the distal end so there can be no perceived coating issue 10cm from the tip.The coating at the proximal end of the wire appeared intact.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: 8639675
• Report Number: 1220452-2019-00068
• Device Sequence Number: 2274845
• Product Code: DQX
• UDI-Device Identifier: 00643169452633
• UDI-Public: 00643169452633
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140695
• 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): 09/17/2019

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: 08/23/2019
• Device Catalogue Number: ZNGRMS180S
• Device Lot Number: G16A06220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/23/2019; 08/19/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/19/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 108