MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

Model Number	1002703-02
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily tortuous and heavily calcified lesion in the left common iliac artery.The ht supra core.035 guide wire was advanced without issue; however, during removal resistance was felt with the anatomy.The guide wire was pulled harder and the wire came out.Once outside the patient it was noted that the guide wire was unraveled at the tip, the coils detached but remained on the wire.Nothing remained in the patient.An unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 2017- excessive force a visual and dimensional inspections were performed on the returned guide wire.The reported break and stretched coils were confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.It should be noted that per hi-torque supra core 35, ce/fda instructions for use (ifu): always advance or withdraw the guide wire slowly.Never push, auger, withdraw or torque a guide wire which meets resistance.In this case, pulling the guide wire hard to remove did not cause or contribute to the reported failure to advance.Additionally, pulling the guide wire hard during removal of the guide wire seemed to be a reasonable clinical response to the difficulties.The investigation determined that the reported difficulty to remove, break and stretched coils appears to be related to operational circumstances of the procedure.Based on the reported information and returned analysis, it is likely that manipulation of the guide during the advancement and/or the procedure, the guide wire¿s distal end became kinked resulting in the difficulty to remove during retraction against the anatomy.Manipulation against resistance during retraction ultimately resulted in the reported break, stretched coils and the corkscrew appearance on the core.The noted bends on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11117301
• Report Number: 2024168-2021-00074
• Device Sequence Number: 19097622
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 07/31/2022
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 0082561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 50