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

Model Number	1011880
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
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.
Event or Problem Description
It was reported that the procedure was to perform a pulmonary balloon valvuloplasty.When attempting to remove a 014 ht balance middleweight elite guide wire three anti-clockwise turns were performed and the wire began to unravel.The outer core of the wire was removed; however, the inner core remained in the patient.Several attempts were made to remove the separated portion; however, it was unsuccessful.On (b)(6) 2022, the patient was sent to surgery to remove the separated portion.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed, it was reported that the ht balance middleweight elite guide wire met resistance during removal with guide catheter.Snaring was attempted; however, was unsuccessful.The device was removed by median sternotomy.Limited force was applied once resistance was felt.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection were performed on the returned device.The reported core separation and break was confirmed as a coil separation.The reported difficulty during removal could not be tested due to the device condition.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatments appear to be related to operational circumstances.Factors that may contribute to difficulty removing the guide wire through the guide catheter include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or guide wire.In this case, based on the returned device analysis and the information provided, it is unknown what may have contributed to the reported difficulty during removal.Analysis of the returned device noted the shaping ribbon was twisted/separated and the coils were stretched/separated.This is consistent with manipulation against resistance.It is possibly that the resistance encountered during removal contributed to the noted shaping ribbon separation and coil stretching/separation.Additionally, the shaping ribbon and coils were separated distal to the center solder, indicating the separation was likely due to a kink/bend and not a product quality issue.The separated portion of the guide wire was reportedly removed via median sternotomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17990106
• Report Number: 2024168-2023-11734
• Device Sequence Number: 17956929
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783(17)241031(10)2111461
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 10/31/2024
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 2111461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 06/13/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/31/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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; Hospitalization
• Patient Sex: Unknown