MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. PressureWire¿; WIRE, GUIDE, CATHETER

Model Number	C12059
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: inserted a pressure wire into the lad "[left anterior descending]" vessel.Was able to equalize and pair, wire was placed in appropriate position per the physician, went to snap the recording and pressure wire was no longer connected.Attempted to reconnect, would not work.Had to remove pressure wire from body and use a new one which worked without issue.

• Brand Name: PressureWire¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd; westford MA 01886
• MDR Report Key: 50378930
• Report Number: 50378930
• Device Sequence Number: 10454741
• Product Code: DQX
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2026
• Report Date (Section F): 08/19/2026

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 Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 60526G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 117 LB
• Date Report Sent to FDA: 08/19/2026