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

Model Number	C12059
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during delivery of the pressurewire x (pwx) to the left anterior descending (lad) coronary artery target lesion, resistance was met, possibly due to the tortuous anatomy.It was also possible that the resistance was with the guide catheter itself (two side holes, so it is also possible that the pwx may have passed through a side hole, resulting in the loss of torque control.) the torque response became ineffective partway through advancement, and the pwx could not reach the target lesion in the mid lad.During advancement of the pwx, the guiding catheter (gc) jumped.The pwx was visualized in the aorta at this point.Upon withdrawing the pwx, a wire break (fracture) was noted approximately 30 cm from the distal tip (between the gold section and the green ptfe coating of the pwx), with the distal fragment remaining attached to the guiding catheter.After the guiding catheter was carefully removed from the body, the distal fragment of the pwx was removed together with it, without resistance.Once outside the body, the pwx distal fragment detached from the guiding catheter.The lesion was re-imaged using the same guiding catheter, and since no significant issues were identified, the procedure was completed without performing ffr.There were no adverse patient effects.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 was performed on the returned device.The reported failure to advance was not able to be confirmed, but the reported material separation was visually 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 failure to advance and material separation appears to be related to circumstances of the procedure.The guidewire was returned with kinks and bends, which caused the reported and confirmed material separation and failure to advance.In this case, it is likely that the guidewire damage was caused by the use or handling techniques employed.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: 24549879
• Report Number: 2024168-2026-00958
• Device Sequence Number: 20249570
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)270930(10)51024G2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 51024G2
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDIKIT 5F SEIHA JL3.5 GUIDING CATHETER
• Patient Sex: Unknown