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

Model Number	1009665
Medical Device Problem Codes	Material Separation (1562); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 the procedure was to treat a moderate to heavy calcified anterior tibial artery.The hi-torque balance middleweight universal ii guide wire was placed in the vessel and an unspecified balloon was used for support.During removal of the balloon the guide wire separated 30-40cm from the distal tip and the separated portion was seen in the patient.The detached separated portion was removed via snare.Another device was used to successfully complete the procedure.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported material too soft / flexible could not be tested as it was based on operational context.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 determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that the wire required stabilization during use (material too soft / flexible).In this case, analysis of the returned wire noted a kink on the nitinol core.A kink in the core could impact a wires maneuverability within the anatomy, possibly contributing to the reported stabilization issue.Additionally, a kink on the core would impact a balloon catheters clearance when moving over the wire, contributing to an interaction between the devices.It was reported that an interaction between the wire and catheter resulted in a wire separation.Analysis confirmed the separation at the hypotube.The separation face was jagged and angular, suggesting the wire was manipulated at a kink or bend.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• 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: 20087040
• Report Number: 2024168-2024-10139
• Device Sequence Number: 7599517
• Product Code: DQX
• UDI-Device Identifier: 08717648118722
• UDI-Public: (01)08717648118722(17)241231(10)3012771
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 12/31/2024
• Device Model Number: 1009665
• Device Catalogue Number: 1009665
• Device Lot Number: 3012771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic
• Patient Race: White