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

Catalog Number	1009666J
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca) with no calcification.The ht balance middleweight universal ii guide wire was being advanced and 20 minutes after the procedure was initiated the hydrophilic coating began to grab [have resistance].There was resistance during removal with an unspecified balloon dilatation catheter; however, the device was removed as a single unit.There was a delay in the procedure and the patient had to be administered a contrast dose about 3 times higher than usual.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.
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing the guide wire include, but are not limited to, interaction with challenging anatomy, procedural contaminants, damage to the guide wire, or device support.Factors that may contribute to difficulty removing the guide wire with the 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 information provided and because the device was not returned for analysis, a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the initially filed report, the account stated that there was no adverse patient effect due to the additional contrast and fluoroscopy.No additional information was provided.

• 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: 17768993
• Report Number: 2024168-2023-10189
• Device Sequence Number: 6273231
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: 08717648118777
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/16/2023

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: 08/31/2024
• Device Catalogue Number: 1009666J
• Device Lot Number: 2091671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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: Other
• Patient Sex: Unknown