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

Model Number	1001780J
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
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 advance and remove; however, the reported irregular texture is likely due to operational context.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The two nc traveler devices referenced in b5 and d10 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the right coronary artery that was both moderately calcified and tortuous.After crossing the mid lesion with a balance middleweight (bmw).014 guide wire, the 3.0x12mm nc traveler was used for pre-dilatation.Resistance was met during advancement and removal on the guide wire.After stent deployment, a 3.5x8mm nc traveler was used for post-dilatation.The same resistance was found during advancement and retraction and the balloon became stuck on the bmw guide wire.Both the balloon and guide wire were removed together from the guide catheter to prevent damaging the artery.After removal of the devices, based on the tactile feel of the guide wire, it was thought that the nc traveler balloon was catching the guide wire firmly and was removing hydrophilic coating on the guide wire.No additional information was provided.

• 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: 16799756
• Report Number: 2024168-2023-04262
• Device Sequence Number: 12371238
• 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
• Report Date (Section B): 04/24/2023

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: 2092171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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: DILATATION CATHETER: NC TRAVELER (X2).
• Patient Sex: Unknown