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

Model Number	1001780-HC
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery.The hi-torque (ht) balance middleweight (bmw) hydro guide wire was advanced and a non-abbot stent was implanted.However, the distal tip of the guide wire got stuck with the implanted stent and the guide wire could not be removed.The physician intentionally fractured about 20mm from the proximal end of the device and the rest of the guide was left in the patient while an intra-aortic balloon pump (iabp) was placed.The patient was transferred to another facility wherein surgery was performed to remove the rest of the device.Nothing remained in the patient.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 2017- failure to follow steps / instructions.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.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.It was reported that when the guide wire met resistance during removal, the wire was cut.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, the deviation was a response to the reported difficulty during removal.The investigation determined the reported difficulties and treatments appear to be related to the operational context of the procedure.It was reported that after the deployment of a stent, the guide wire interacted with the deployed stent, resulting in resistance during removal.In response to the difficulty during removal, the physician cut the wire, resulting in the reported material separation.The separated portion of the wire was surgically removed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: medical device problem code 1562 removed.

• 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: 20591547
• Report Number: 2024168-2024-12861
• Device Sequence Number: 6529197
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(17)260531(10)4060671
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 05/31/2026
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 4060671
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC STENT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown