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

Model Number	1010482-H
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned 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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced resistance was met with the heavily calcified, mildly tortuous mid right coronary artery (rca) with 100% stenosis resulting in the reported failure to advance.Interaction with the heavily calcified anatomy and/or manipulation of the device resulted in the difficulty to remove and stretched coils.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 the heavily calcified, mildly tortuous mid right coronary artery (rca) with 100% stenosis.The pilot 200 guide wire was advanced but could not cross the lesion due to the anatomy.The guide wire was removed and reshaped to a knuckle shape and again the guide wire could not cross.During removal there was resistance and the tip became wavy and the coils were stretched.It was confirmed by the account that there was no separation or break.Another unspecified guide wire was used to continue the procedure and balloon dilatation was performed.There were no adverse patient effects and there was no clinically significant delay in 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: 11009079
• Report Number: 2024168-2020-10500
• Device Sequence Number: 3823210
• 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
• Report Date (Section B): 12/14/2020

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: 06/30/2022
• Device Model Number: 1010482-H
• Device Catalogue Number: 1010482-H
• Device Lot Number: 0072371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1