MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEELCORE 18 LT GUIDE WIRE

Model Number	1007710
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reportedly retained by the facility.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the left pulmonary artery.The non-abbott guide catheter was placed and 018 steelcore guide wire was advanced distally from the guide catheter to serve as a guide for the cardiomems delivery system to be placed.A "gap" was noted on the xray in the distal tip of the guide wire.The guide catheter was advanced and the guide wire pulled into the guide catheter and removed without issue.Once outside the anatomy the guide wire covering "coils" looked frayed and unraveling.A new guide catheter and guide wire used to prepare for the cardiomems placement.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequent information was reported that the guide wire coils were stretched and wavy.No additional information was provided.
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned for analysis.A review of the electronic lot history record and similar incident query for this product was not performed since the lot number was not reported.The investigation was unable to determine a conclusive cause for the reported stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 1069 was removed and replaced with 1601.

• Brand Name: HI-TORQUE STEELCORE 18 LT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15283195
• Report Number: 2024168-2022-09083
• Device Sequence Number: 16726637
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: 08717648014123
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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 Model Number: 1007710
• Device Catalogue Number: 1007710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 110 KG