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

Catalog Number	ZNGRS180HS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a zinger guidewire in a moderately tortuous lesion.There was no damage noted to packaging.There were no issues noted when removing the device from the packaging.The device was not inspected.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Excessive force was not used during insertion/delivery.It is reported that the guidewire became stuck in the electrode of another device in use at the time and after removal from the patient it was noted that a portion of the zinger device detached in vivo and remains in the patient.No patient injury is reported.
Additional Manufacturer Narrative
The procedure was performed via the vena subclavia.No attempt to remove the detached portion of the zinger wire was made as it broke during removal of the wire out of the attain device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the picture provided shows two devices in the anatomy on the left and what looks like possibly a tip portion of a guide wire tip in a figure 8 on the right side of the image.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: as received the distal end of the guide wire is missing, the coil wire unraveled in a distal direction.The core wire is broken, and the distal end of the wire and coil wire are missing.The core wire is broken approx 27.5 cm from the distal bond joint indicating approx 2 cm of the distal end of the wire (including distal bond and tip) is missing.The wire is bent 90 degrees, 15cm distal to the proximal bond.The proximal bond is stretched in a distal direction.The broken end of the core wire shows a curve.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: 7117063
• Report Number: 1220452-2017-00135
• Device Sequence Number: 19115355
• Product Code: DQX
• UDI-Device Identifier: 20643169452576
• UDI-Public: 20643169452576
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140695
• 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,Followup
• Report Date (Section B): 06/06/2018

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: 08/22/2019
• Device Catalogue Number: ZNGRS180HS
• Device Lot Number: G16A06224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 03/21/2018; 05/11/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/29/2018; 04/17/2018; 06/06/2018
• 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: Other
• Patient Age: 76 YR