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

Model Number	GWR419588
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
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, the tip of the guidewire detached and remained in the coronary sinus.It was noted to be the thin black part of the guidewire.Another guidewire was used for implant.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the stylet/guidewire was broken.The sty let/guidewire was damaged.The stylet/guidewire was kinked/buckled.The guidewire was unraveled.Visual analysis of the guidewire indicated damage during use.The analyst noted the attain guidewire was returned.The guidewire is kinked at various locations at the distal end of the guidewire.The coating on the guidewire is coming off on the distal end of the guidewire.The guidewire is unraveled at the distal end of the guidewire.The distal end of the guidewire is broken.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN HYBRID GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9548911
• Report Number: 1220452-2020-00002
• Device Sequence Number: 2283218
• Product Code: DQX
• UDI-Device Identifier: 00643169452411
• UDI-Public: 00643169452411
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/06/2020

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: 03/06/2021
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0009648512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 103