MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. PRESSUREWIRE¿; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	C12059
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pressurewire x, wireless device was to be used in the left circumflex (lcx) lesion.It was noted the vessel itself was heavily calcified and tortuous/kinked.It was difficult to remove and difficult to advance due to the anatomy.However, during intervention, the tip was torn/ripped off.The tip was stented into the vessel.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis were performed on the returned device.The reported material separation was confirmed; however, the reported difficulty to advance and remove the guidewire from the anatomy were not able to be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty to advance and remove the guidewire from the anatomy which caused material separation and resulted in the device (distal tip) embedded in tissue or plaque appears to be related to circumstances of the procedure.The device was returned with kinks and a separation of the distal tip coil/corewire, which is consistent with the reported material separation and difficulty to remove from the anatomy.In this case, it is likely that the patient¿s anatomical conditions (heavy tortuosity and heavy calcification) caused the reported difficulty to advance and resulting guidewire damage/separation.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PRESSUREWIRE¿
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24888946
• Report Number: 2024168-2026-01547
• Device Sequence Number: 9897360
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)271031(10)51112G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 51112G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown