MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES

Model Number	1001780J
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
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 udi number is not known as the part and lot number was not provided.The additional vascular device referenced in b5 is filed under separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, heavily tortuous left main artery.The 4.50x8mm nc trek would not deflate; however, after multiple deflations the device was pulled into the catheter and noted it was removed not inflated.Resistance was noted during removal with the unspecified balance middleweight guide wire.Another unspecified device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed it was noted the nc trek balloon was slow to deflate and removed fully deflated through the catheter.No additional information was provided.
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 identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to remove.Factors that may contribute to difficulty removing the balloon dilation catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, 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 difficult to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES
• 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: 16920185
• Report Number: 2024168-2023-05107
• Device Sequence Number: 6921545
• Product Code: DQX
• UDI-Device Identifier: 08717648025976
• UDI-Public: 08717648025976
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K021228
• 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): 06/09/2023

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: 08/31/2024
• Device Model Number: 1001780J
• Device Catalogue Number: 1001780J
• Device Lot Number: 2092771
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.50X8MM NC TREK.
• Patient Sex: Unknown