MAUDE Adverse Event Report: ABBOTT VASCULAR HT PILOT; GUIDE WIRE

Catalog Number	1010480-H
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 a hi torque pilot 50 guide wire felt resistance with an unspecified intravascular ultrasound catheter, and the guide wire felt sticky.Resistance was felt removing the guide wire from the catheter.However, the devices were able to be removed separately without other issues.A new 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
The device was not returned.A review of the electronic lot history record and similar incident query for this product was not performed since the lot number was not reported.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Exemption number e2019001.

• Brand Name: HT PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9036656
• Report Number: 2024168-2019-11780
• Device Sequence Number: 2882657
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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): 10/14/2019

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 Catalogue Number: 1010480-H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1