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

Catalog Number	ZNGRS180HS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
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 intended to be used during a procedure.The device was placed in the coronary sinus (cs).No damage noted to packaging.No issues removing the device from the packaging as per ifu.Device was inspected and prepped as per ifu.The wire tip was not formed by the physician.Excessive force was not used during delivery.It is reported that damage was noted to the device after removal from the patient.Resistance was experienced during removal.The wire had been placed beside the 4798-88 cm attain stability quad and both were in a 6250vi-eh attain command.During removal of the wire, the outer wrapping of the wire was damaged.No part of the wire was left in the patient.It is indicated that the physician pulled the wire forcefully and this is what may have damaged the device.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: as received, the wire is severely unraveled and exhibiting broken coils and broken core wire.The core wire broke 27cm from the proximal joint, a piece of the remaining broken core wire remained attached to the first joint measuring approximately 7mm.Although the distal joint is kinked and severely bent, the first joint and the tip ball remained as a unit.No missing pieces of the wire whole length of the wire were detected.Wire whole length measured approximately 183cm per specification 182 ± 3 cm.Wire outer diameter measured.0135¿ per specification 0.0135¿ maximum along uncoated core wire.Closer visual inspection detected severe bending at the core wire break.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: 8365919
• Report Number: 1220452-2019-00016
• Device Sequence Number: 16549197
• Product Code: DQX
• UDI-Device Identifier: 00643169452572
• UDI-Public: 00643169452572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/15/2019

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: 04/19/2021
• Device Catalogue Number: ZNGRS180HS
• Device Lot Number: G18A04308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 80