MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEELCORE 18 GUIDE WIRE (MDD)

Catalog Number	1003282
Medical Device Problem Codes	Break (1069); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report #mw5153105 states: during the cardiomems insertion procedure, the steelcore 18 wire was inserted into the left pulmonary artery.Once inserted it was noted that the wire had fractured.At the end of the procedure the wire was removed and noted to be fractured, but intact.No wire was left behind in the body.Product information listed below.
Additional Manufacturer Narrative
Attachment medwatch report #mw5153105.The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment nonconformities.The electronic lot history record (elhr) revealed no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that the guide wire was used in the pulmonary artery.It should be noted that the hi-torque guide wires instructions for use (ifu) states: ¿all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).¿ in this case, it is unlikely the deviation contributed to the reported issue.The investigation was unable to determine a conclusive cause for the reported break.Factors that may contribute to a guide wire break during use include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, excessive force, device support, or inadvertent mishandling.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE STEELCORE 18 GUIDE WIRE (MDD)
• 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: 19164914
• Report Number: 2024168-2024-04994
• Device Sequence Number: 18127176
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: (01)08717648013959(17)250731(10)3082361
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 07/31/2025
• Device Catalogue Number: 1003282
• Device Lot Number: 3082361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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: Unknown