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

Model Number	GWR419588
Medical Device Problem Codes	Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
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, part of the guidewire had broken and was visible at the end of the vein.It was noted that when placing the lv lead, the physician removed the guidewire and observed on the fluoroscopic image that part of the guidewire was broken.The part of the guidewire that was broken will remain inside the patient and the remaining part that was removed will be returned.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.Analysis indicated that the stylet/guidewire was broken.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the analyst noted that the guidewire was returned damaged.Guidewire distal end was kinked, and the guidewire distal tip appeared to be broken.The broken part was not received.According to the returned paper work indicated, the broken part was remained in the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7526577
• Report Number: 1220452-2018-00062
• Device Sequence Number: 1696611
• Product Code: DQX
• UDI-Device Identifier: 00643169452411
• UDI-Public: 00643169452411
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 03/29/2018
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0008053689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 08/29/2018; 09/26/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 09/04/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1