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

Model Number	1002703-02
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported break was confirmed.The reported difficult to advance could not be tested due to the device condition.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.It was reported that a stent delivery system (sds) encountered resistance when advancing over the guide wire.Analysis of the returned wire confirm the outer diameter was within specification.Factors that may contribute to difficulty advancing an sds over the guide wire include, but are not limited to, inner diameter of the sds, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the sds or guide wire.In this case, it cannot be determined what contributed to the interaction between the devices.Additionally, it was reported that the wire broke.Analysis confirmed the break as a separation of the proximal solder, resulting in the ribbon coil stretching.In this case, it is possible that manipulation of the sds, when resistance with the wire was encountered, contributed to the noted solder break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (sfa) with heavy calcification.After pre-dilatation, the ht supra core 35 guide wire (gw) was advance to the target lesion and then a non-abbott stent was advanced on the gw with resistance.The stent was noted to partially deploy, prior to entering the sheath and a burr [break] was noted to be on the gw ribbon coil.The stent and gw were removed.A non-abbott gw and an unspecified stent were used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Outside the patient the physician manipulated the burr and a piece of the ribbon coil came off on the physician's glove.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: 21748685
• Report Number: 2024168-2025-03393
• Device Sequence Number: 9437425
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: (01)08717648033001(17)260930(10)4102362
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 09/30/2026
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 4102362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White