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

Catalog Number	010388
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the wire was received in a hoop with dried residual media.Analysis revealed severe damage to the distal coiled section of the wire.The wire exhibited kinks, coils separation and bunched up coils.On removal from the hoop the wire was noted to be wavy along the length of the wire.Inspection of the very distal tip detected no damage to the wire tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An angiographic wire was used during a procedure.The lesion was located in the coronary sinus ostium (during a crt implant).No damage noted to packaging.No issues removing the device from the packaging as per ifu.The device was inspected and prepped per ifu with no issues.The wire tip was not formed by the physician.It was reported that damage was noted to the device after removal from the patient.The physician used the angiographic wire inside an attain command catheter to access the coronary sinus.After trying to pass the superior vena cava (atrial and rv lead were previously implanted - during the same procedure) the physician noted that the guide wire was kinked.The procedure was completed using another 0.025" wire.No patient injury reported.Analysis revealed coils separation.
Additional Manufacturer Narrative
Analysis of the device confirmed that the ends were properly sanded and the ptfe coating was acceptable and uniform across the entire length of the guide wire.Kinks were noted to be at 3cm.Investigators were able to manipulate the j at the distal end of the wire and could not stretch the outer spring.This indicates that the safety wire was properly secured at each end of the spring.Measurements taken all met specification.It was confirmed based on the assessment that the device was manufactured correctly and meets all specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8486647
• Report Number: 1220452-2019-00042
• Device Sequence Number: 1928174
• Product Code: DQX
• UDI-Device Identifier: 00643169857278
• UDI-Public: 00643169857278
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K082873
• 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): 06/20/2019

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: 05/28/2023
• Device Catalogue Number: 010388
• Device Lot Number: GFCS2820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1