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

Model Number	1011880
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2024
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.B3: date of the procedure estimated to (b)(6) 2024.
Event or Problem Description
User facility medsun report received that states: "interventional wire broke within coronary vessel.Fragment remains in body." no additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separaiton was confirmed.The reported entrapment 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.It was reported that a force was applied during removal of the guide wire.It should be noted that the hi-torque guide wires for ptca, pta, stents instructions for use (ifu) states: ¿do not push, auger, withdraw, or torque a guide wire that meets excessive resistance.¿ in this case, the deviation appears to be a reasonable clinical response.It was reported that the guide wire was intentionally jailed.It should be noted that the hi-torque guide wires for ptca, pta, ifu states: ¿do consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.¿ in this case, the ifu deviation appears to be a reasonable clinical response.The investigation determined the reported difficulties, patient effect, and treatment appear to be related to user error.In this case, it was reported that the guide wire was intentionally jailed as part of a bifurcation procedure.It is likely manipulation of the wire, after it was entrapped (jailed), contributed to the reported material separation.Analysis of the returned device confirmed the reported separation.The separation occurred at a solder weld, this type of damage is consistent with manipulation against resistance.The separation portion of the stent was reportedly embedded into the vessel with a stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B3, b6 correction: dates updated h6 correction: health effect clinical code 2687 was removed and replaced with code 3165; health effect impact code 4614 was removed and replaced with code 4641.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the procedure was to treat a lesion in the bifurcation of the left circumflex artery with calcification.Resistance was noted when removing the guide wire, therefore, force was applied and the guide wire separated in the patient.Therefore, a stent was implanted to embed the separated portion on the stent.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• 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: 20444986
• Report Number: 2024168-2024-12113
• Device Sequence Number: 8090788
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783(17)251231(10)4011971
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 12/31/2025
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 4011971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White