MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE WHISPER¿ MS Guide Wire with Hydrophilic Coating; Wire, Guide, Catheter

Model Number	1005357H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to perform electrophysiology in the coronary artery.The whisper ms guide wire was used in the patient however after the guide wire was removed, fluoroscopy confirmed that a portion of the guide wire remained in the patient.Several attempts were made to retrieve the separated portion with partial success.A small fragment migrated to the distal pulmonary artery and was determined to be too far to retrieve therefore it was left in the patient.Per the physician, the remaining portion was not expected to cause clinical issues for the patient.A delay in the procedure was reported.No additional information was provided.
Event or Problem Description
It was reported the procedure was to perform electrophysiology in the coronary artery.The whisper ms guide wire was used in the patient however after the guide wire was removed, fluoroscopy confirmed that a portion of the guide wire remained in the patient.Several attempts were made to retrieve the separated portion with partial success.A small fragment migrated to the distal pulmonary artery and was determined to be too far to retrieve therefore it was left in the patient.Per the physician, the remaining portion was not expected to cause clinical issues for the patient.A delay in the procedure was reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported difficulty could not be determined.The subsequent treatment appears to be related to circumstances of the procedure.Factors that may contribute to a material separation include, but are not limited to, tensile strength, corrosion, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: HI-TORQUE WHISPER¿ MS Guide Wire with Hydrophilic Coating
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50472762
• Report Number: 2024168-2026-03340
• Device Sequence Number: 9972518
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: (01)08717648037801(17)270531(10)5061672
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 5061672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• Patient Sex: Male
• Patient Weight: 275 LB