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

Model Number	1001780J-HC
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported deformation due to compressive stress was confirmed.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 deformation due to compressive stress.It was reported that the guide wire was bent (deformation due to compressive stress) after removal from the packaging.Analysis of the returned wire confirmed the reported deformation on the shaping ribbon.Factors that may contribute to damage during unpackaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, or inadvertent mishandling during unpacking or preparation.In this case, it cannot be determined when the deformation was introduced.It is possible that the deformation occurred during unpackaging, however, this cannot be confirmed.Additionally, the analysis noted a separation of the distal solder tip.This type of separation can occur due to corrosion, when the wire is exposed to environmental factors during return.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that when the balance middleweight (bmw) hydro guide wire was removed from the protective cover, a bend in the body of the wire was noted.There was no device use or patient involvement.Another bmw guide wire was used to complete the procedure.There was no clinically significant delay in the procedure.Returned device analysis identified that there was a separation at the distal solder tip.No additional information was provided.

• 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: 20801520
• Report Number: 2024168-2024-14057
• Device Sequence Number: 17866242
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: (01)08717648025983(17)241031(10)2112271
• 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
• Report Date (Section B): 11/27/2024

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: 10/31/2024
• Device Model Number: 1001780J-HC
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 2112271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Patient Sex: Male