MAUDE Adverse Event Report: ABBOTT VASCULAR HI TORQUE SUPRA CORE 35; GUIDE WIRE

Model Number	1002703-02
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a patient with a type iii arch, high-grade 80-85% dissected right common internal carotid artery.Reportedly, the weld on the supracore was too large and became stuck in the 5fr non-abbott guiding catheter during advancement.The devices were removed and the procedure was completed as expected with a new supracore guide wire and another non-abbott guiding catheter.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned to abbott vascular 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 reported from this lot.Factors that may contribute to the inability to advance/position or remove the guide wire and cause resistance between the devices may include, but not limited to, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire or guiding catheter, coagulation of blood or procedural contaminates.The investigation was unable to determining a conclusive cause to the reported oversized guide wire.The reported difficulty to advance and remove the guide wire through the guiding catheter appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI TORQUE SUPRA CORE 35
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9512216
• Report Number: 2024168-2019-14940
• Device Sequence Number: 1410155
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 05/31/2021
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 9061961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/01/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR 100CM COOK VTK CATHETER
• Patient Age: 77 YR
• Patient Weight: 79