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

Model Number	1010480-H
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
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.Based on the review of similar incidents there is no indication of a lot specific product quality issue.The investigation determined the reported failure to advance and difficulty to remove appear to be related to operational circumstances of the procedure.In this case, based on the reported information, during advancement, the guide wire encountered resistance with the moderately calcified, heavily tortuous and 99% stenosed anatomy which resulted in the reported failure to advance and difficulty to remove.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 located in the left circumflex (cx) artery that was moderately calcified, heavily tortuous and 99% stenosed.The pilot guide wire failed to cross the lesion; thus, did not advance to the desired location.During removal, resistance was noted.There was no adverse patient effect or a clinically significant delay in procedure.Another guide wire was used to continue the procedure.No additional information was provided.

• 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: 11617030
• Report Number: 2024168-2021-02774
• Device Sequence Number: 11665168
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 05/31/2022
• Device Model Number: 1010480-H
• Device Catalogue Number: 1010480-H
• Device Lot Number: 0062371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1