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

Model Number	1001780-HC
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medsun mandatory and voluntary report form # (b)(4) received, reporting: describe the event or problem: patient was in cath lab for inferior wall stemi [st-segment elevation myocardial infarction] and had 2 stents placed in rca [right coronary artery].The ivus [intravascular ultrasound] was used afterwards to ensure the stents were properly placed and deployed in the coronary artery.When ivus imaging was done the catheter could not be removed without also removing the guidewire at the same time.Ivus catheter and guidewire were removed together, as a single unit.It appears that ivus catheter got stuck on the wire.No harm to patient but could have potentially caused hard if a guidewire was still needed.
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 issues could not be determined.Factors that may contribute to difficulty removing an ivus catheter over 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, inadequate hydrophilic coating on guide wire and/or damage to the ivus catheter and/or damage to the guide wire.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.Medsun mandatory and voluntary report form attached.

• 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: 22044065
• Report Number: 2024168-2025-05172
• Device Sequence Number: 9017659
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(11)241212(17)261130(10)4121271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 4121271
• 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: 05/06/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 89 KG