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

Model Number	1009666J
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that when attempting to advance a 4.5x20mm nc trek balloon dilatation catheter (bdc) it would not advance.During removal the bdc met resistance with the.014 balance middleweight universal ii guide wire.It was noted that both devices had to be removed together as one unit.On the guide wire a small relief [unknown damage] was observed just before the beginning of the radiopaque mark and the shaft of the bdc was noted to be damaged.Another guide wire and balloon were used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported product quality problem (unknown damage) was confirmed.The reported difficult to remove 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.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that the guide wire encountered resistance with the balloon catheter during removal.Analysis of the returned device confirmed the outer diameter to be within specification.Additionally, the analysis noted stretched coils and damaged polymer.This type of damage could impact the catheters maneuverability over the wire.It is possible that the wire sustained damage during use, resulting in the reported resistance during removal.Manipulation of the wire, when resistance was met, possibly contributed to further polymer/coil damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Returned device analysis noted that the nc trek balloon outer member returned torn and the balance middleweight universal ii guide wire polymer coating was separated; however, still held by the guide wire core.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• 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: 19628559
• Report Number: 2024168-2024-07746
• Device Sequence Number: 15606002
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)250630(10)3071471
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 06/30/2025
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 3071471
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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: 4.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC).
• Patient Sex: Unknown