MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number	1009666
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the calcified left anterior descending (lad) coronary artery.During use, the balance middleweight universal ii guide wire was advanced to the lesion without resistance.An unspecified stent was implanted in another branch and jailed the guide wire.There was resistance during removal and force was applied.The guide wire tip separated and was attempted to be removed by snare but was unsuccessful.The tip remains free floating in the patient.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
B3: date of event estimated d4: the udi is unknown because the part/lot number were not provided.H6: medical device problem code 2017 - excessive force h6: medical device problem code 2017 - failure to follow steps / instructions manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
B3: date of event updated from 2/1/2024 to 2/5/2024.B6: relevant test/laboratory data updated from 2/1/2024 to 2/5/2024.D4: lot number updated from unknown to 3030871.A visual inspection of the returned device was performed.The reported material separation was confirmed.The reported difficult to remove could not be tested due to the device condition.The reported device damaged by another device could not be tested as it was based on operational context.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The electronic lot history record (elhr) identified no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that a stent was implanted in a way, such that, the guide wire became jailed.It should be noted that the hi-torque balance middleweight universal ii instructions for use, states: ¿do not: deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ in this case, it is likely that the reported issues of difficulty during removal, material separation, and guide wire damage, were a result of the guide wire being jailed and subsequent manipulation used to remove the wire.Additionally, it was noted that the separated guide wire tip remains free floating in the patient¿s anatomy.It was reported that when resistance was encountered, excessive force was applied to the wire.It should be noted that the hi-torque balance middleweight universal ii instructions for use, states: ¿do not: push, auger, withdraw, or torque a guide wire that meets resistance.¿ in this case, it was noted that the guide wire was jailed; therefore, the deviation appears to be a reasonable clinical response to the difficulty.The investigation determined the reported difficulties, patient effect, and treatment appear to be related to user error.It was reported that a stent was implanted in a way, such that, the guide wire became jailed.It should be noted that the hi-torque balance middleweight universal ii instructions for use states: ¿do not: deploy a stent such that it will entrap the wire between the vessel wall and the stent.¿ in this case, it is likely that the reported issues of difficulty during removal, material separation, and guide wire damage, were a result of the guide wire being jailed and subsequent manipulation used to remove the wire.Additionally, it was noted that the separated guide wire tip remains free floating in the patient¿s anatomy.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18888078
• Report Number: 2024168-2024-03218
• Device Sequence Number: 3038054
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: (01)08717648118739(17)250228(10)3030871
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K072460
• 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): 04/25/2024

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: 02/28/2025
• Device Catalogue Number: 1009666
• Device Lot Number: 3030871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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 Sex: Unknown