MAUDE Adverse Event Report: ABBOTT VASCULAR HT COMMAND 18; GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.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 prior to use, a cardiomems sensor delivery catheter was advanced over a hi-torque command 18 guide wire, but resistance was felt between the two devices during advancement and removal.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional and functional inspection were performed on the returned guide wire.The reported difficulty to advance/position and remove were unable to be confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.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.Na.

• Brand Name: HT COMMAND 18
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10344393
• Report Number: 2024168-2020-06320
• Device Sequence Number: 11612712
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• 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): 09/03/2020

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: 02/28/2022
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 0031761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOMEMS SENSOR