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

Model Number	1001780J
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the great saphenous vein.During the use of a 3cm 014 ht balance middle weight guide wire (gw) the tip of the wire was noted to separate.The separated portion was left in the anatomy and a compressive coban bandage was applied to the upper thigh along with a compression sock to ensure the separated portion of the wire would not migrate.After the location of the separated wire was confirmed under ultrasound the patient was transferred to another hospital.There were no adverse patient sequela nor clinically significant delay in procedure 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.H6: medical device problem code 1494 - incorrect anatomy.
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.The guide wire was used in the great saphenous vein.The instructions for use (ifu) for hi-torque guide wire 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).It is unknown if the reported ifu deviation contributed to the reported difficulties.Based on the information received, 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 difficulty advancing the guide wire include, but are not limited to, outer diameter of the guide wire, challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire which likely led to the reported material separation.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.E1 correction: first, last name updated.E1 correction: title updated.E3 correction: occupation updated.E4 correction: initial report sent to fda updated from no to yes.G2 correction: report source updated.H6 correction: health effect - clinical code 2687 removed, 4582, 4624, h6 correction: medical device problem code 2524 added.Attachment: medsun report.
Event or Problem Description
Subsequent the initially reported information, additional information was received and it was noted that the balance middle weight (bmw) guide wire was loaded through the support catheter to the lower left gsv and slowly advanced to the thigh area under ultrasound guidance.Subsequently, the catheter was pushed over the bmw in an attempt to guide it into the left gsv rather than an accessory vein.At this point, the catheter tip was immediately below the left knee, but further advancement was impossible due to resistance.Attempts were made to reposition the bmw, and ultimately the guide wire was removed; however, during this process, the terminal flexible part of the bmw guide wire separated from the stiff shaft and remained in the mid-lower left thigh area of the gsv.The stiff portion of the guide wire was removed intact.The failure of the wire device was recognized, with two parts of the guide wire having broken apart, one remaining in the patient¿s anatomy.After the position of the separated portion was held by coban bandaged and a compression sock, the patient was transferred to another hospital where the separated wire was surgically removed via a vessel cut down.There were no adverse patient sequela nor clinically significant delay in procedure reported.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT¿
• 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: 22152722
• Report Number: 2024168-2025-05801
• Device Sequence Number: 18092471
• Product Code: DQX
• UDI-Device Identifier: 08717648025976
• UDI-Public: (01)08717648025976(11)241113(17)261031(10)4111372
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1001780J
• Device Catalogue Number: 1001780J
• Device Lot Number: 4111372
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 191 KG
• Patient Ethnicity: Hispanic