MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT ELITE; WIRE, GUIDE, CATHETER

Model Number	1011880
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during the procedure the balance middleweight guide wire was attempted to be removed after three turns; however could not be removed.The guide wire was ultimately removed; however, the distal tip remained in the patient's distal lower left pulmonary artery.No clinically significant delay was reported.No additional information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to remove could not be tested due to the device condition.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent patient effect appears to be related to operational circumstances.It was reported that the guide wire encountered resistance during removal from the anatomy.Factors that may contribute to difficulty encountered during removal include, but are not limited to, outer diameter of the guide wire, device support, challenging anatomy, interaction with accessory devices, buildup of procedural contaminants, user technique, and/or damage to the guide wire.Base on the information provided and the returned device analysis, it cannot be determined what contributed to the difficulty during removal.Additionally, it was reported that the guide wire had separated during its removal from the anatomy.Analysis of the returned wire noted the shaping ribbon, at the separation, was in a corkscrew shape.This type of damage indicates the tip was subject to torsional force while the tip encountered resistance, possibly contributing to the separation.Analysis also noted stretched and misaligned coils.This type of coil damage is consistent with a tip separation.The separated portion of the guide wire remains within the patient¿s anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20010267
• Report Number: 2024168-2024-09793
• Device Sequence Number: 4325602
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783(17)241130(10)2120871
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 2120871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown