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

Model Number	GWR419688
Medical Device Problem Codes	Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
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
It was reported that during the implant procedure, after the left ventricular (lv) lead was placed, the physician was unable to remove the guidewire from the lead.It was noted that the guidewire was folded backwards, and the physician applied force to remove the guidewire causing it to break.It was further reported that the distal portion of the guidewire was trapped inside the lead and the other part was located outside of the lead and inside the patient vein.The implanting physicians decided to leave the broken portion of the guidewire inside the patient.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8488766
• Report Number: 1220452-2019-00043
• Device Sequence Number: 2384070
• Product Code: DQX
• UDI-Device Identifier: 00643169452398
• UDI-Public: 00643169452398
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K143316
• 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
• Report Date (Section B): 04/05/2019

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: 08/02/2020
• Device Model Number: GWR419688
• Device Catalogue Number: GWR419688
• Device Lot Number: 0009272582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR