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

Model Number	1001780J-HC
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an.014 hi-torque balance middleweight hydro guide wire was placed; however, inflating the 3.5x23mm xience alpine stent to 16 atmospheres the balloon of the delivery system became stuck with the guide.Therefore, the delivery system and guide wire were removed together.There was no adverse patient effects and no clinically significant delay in the procedure.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.The additional device referenced in b5 is filed under a separate medwatch report number.B3: date of event estimated to (b)(6) 2024.H6: medical device problem code 2017 - excessive force.
Additional Manufacturer Narrative
The device was not returned for analysis.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 when the guide wire met resistance.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 appears to be a reasonable clinical response.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the stent delivery catheter met resistance with the guide wire during advancement.Factors that may contribute to difficulty advancing a catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during advancement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20587161
• Report Number: 2024168-2024-12822
• Device Sequence Number: 8787606
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: (01)08717648025983(17)251031(10)3112271
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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 Expiration Date: 10/31/2025
• Device Model Number: 1001780J-HC
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 3112271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 X 23 MM XIENCE ALPINE STENT
• Patient Sex: Unknown