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

Model Number	C12009
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the pressurewire x, cabled device had no signal and calibration was unsuccessful.Therefore, the device was not used in the patient and another pressurewire x, cabled device was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis found the distal tube was kinked 3.4 centimeters proximal to the distal tip.The distal tube was torn at the noted kink, exposing the microcables.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported communication problem was 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 communication problem appears to be related to circumstances of the procedure.The catheter was returned kinked and bent in multiple locations, which caused damage to the internal components of the device, a tear to the distal tube, and the reported communication problem.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: 24818490
• Report Number: 2024168-2026-01421
• Device Sequence Number: 9601018
• Product Code: DXO
• UDI-Device Identifier: 05415067025739
• UDI-Public: (01)05415067025739(17)260331(10)40406G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Expiration Date: 03/31/2026
• Device Model Number: C12009
• Device Catalogue Number: C12009
• Device Lot Number: 40406G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2024
• 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
• Patient Sex: Unknown