MAUDE Adverse Event Report: AV-TEMECULA-CT HT COMMAND; GUIDE WIRE

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimated.Concomitant medical products: the unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely that during withdrawal interaction with the anatomy and/or other device resulted in the reported difficult to remove; and thus, resulting in the reported device operates differently than expected.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during a procedure, the command guide wire became sticky and met resistance when attempting to withdraw the guide wire.All devices were removed together as a system without reported issue.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT COMMAND
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8204742
• MDR Text Key: 131738390
• Report Number: 2024168-2018-10086
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1