MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PILOT GUIDE WIRE

Model Number	1010482-H
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with a mid-right coronary artery (rca), heavily calcified lesion.The pilot guidewire failed to advance the lesion.After several advancements attempts and added torque, the tip became floppy.Another unspecified guidewire was used, however, this guidewire also failed to cross the lesion.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided.
Event or Problem Description
Subsequent to the initial medwatch report, the additional information was obtained: the pilot guide wire failed to advance the lesion due to anatomy.After the failure to cross, the tip was unable to hold shape.The core had not separated and the coils had not detached from the core.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined that the reported issue regarding failure to cross and the tip not holding its shape, appears to be related to operational circumstances of the procedure.Based on reported information, during advancement through the heavily calcified lesion, the guide wire failed to cross the anatomy, and likely causing coil damage including resulting in the tip shape issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional information was received reporting that the device tip did not hold its shape and there was no separation.This device malfunction would not be mdr reportable.H6: device code 1069 removed.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9900395
• Report Number: 2024168-2020-03109
• Device Sequence Number: 2378127
• Product Code: DQX
• UDI-Device Identifier: 08717648073892
• UDI-Public: 08717648073892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 01/31/2021
• Device Model Number: 1010482-H
• Device Catalogue Number: 1010482-H
• Device Lot Number: 9022771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1