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

Model Number	C12059
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressurewire x wireless device was removed from the package when it was noted as kinked.There was no patient involvement and no clinically significant delays in the procedure.No additional information was provided.The product return identified a break in the proximal tube of the pressurewire.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported kink was 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 kink appears to be related to circumstances of the procedure.The returned device was noted to be kinked and bent in multiple locations, which resulted in the reported and confirmed deformation due to compressive.One of the kinks caused a break to the proximal tube of the guidewire, which likely resulted from continued handling of the kink.In this case, it is likely that the guidewire damage (kinks, bends, and proximal tube break) was caused by the preparation handling or guidewire removal 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: 24716811
• Report Number: 2024168-2026-01284
• Device Sequence Number: 6087741
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: (01)05415067025715(17)271031(10)51103G2
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 51103G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• Patient Sex: Unknown