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

Model Number	1002703-02
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 peeled/delaminated.It was reported that the coating of the guide wire was incomplete (peeled / delaminated), after removal from packaging.Factors that may contribute to peeled / delaminated after 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, based on the reported information and because the device was not returned for analysis, a conclusive cause for the reported peeled / delaminated cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported during the procedural preparation of a 300cm ht supra core guidewire (gw), that the covering [coating] on the gw was noted to be incomplete, when the device was removed from its package.Therefore, a new supra core gw was used and the procedure was completed.There was no patient involvement nor clinical delay.No additional information was provided.

• Brand Name: HI-TORQUE SUPRA CORE
• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21357958
• Report Number: 2024168-2025-01517
• Device Sequence Number: 8564341
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: (01)08717648033001(17)260430(10)4052461
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K980119
• 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
• Report Date (Section B): 02/11/2025

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: 04/30/2026
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 4052461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: Unknown