MAUDE Adverse Event Report: ABBOTT VASCULAR ILUMIEN OPTIS; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number	C408650
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed in the moderately stenosed, moderately tortuous, and moderately calcified lesion in the let anterior descending artery.The lesion was evaluated and recorded using the optis system and dragonfly catheter before treatment.It showed a lesion length of 38mm.The physician checked the image of angio co-registration (acr) and said the value was wrong.The lesion length was evaluated and recorded again, but the same result was noted.The lesion was remeasured with quantitative coronary angiography (qca) and it measured at 33mm.A 3.5x33mm xience stent was successfully implanted at the lesion.Post stent implantation, the system was measured and recorded, and the stent length was measured at 37mm.It was confirmed that the stent did not elongate, it was the system optis system gave the incorrect measurement.There were no adverse patient effects and no clinically significant delay in the procedure.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
The device was not returned for analysis.A review of the finished product device history record and the corrective action tracking system for the web (catsweb) database for this serial number revealed no nonconforming material records (ncmr)/exceptions).There is no evidence of software issue from reviewing this case.From reviewing the raw data, it seems like the measurements calculated by the algorithm was heavily relied on when it was reported that the lesion length was wrong.The measurements determined by our software is good starting point and should be treated more as guidance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ILUMIEN OPTIS
• Common Device Name: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16914733
• Report Number: 2024168-2023-05081
• Device Sequence Number: 2252069
• Product Code: NQQ
• UDI-Device Identifier: 00183739000678
• UDI-Public: 00183739000678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210458
• 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): 07/17/2023

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: C408650
• Device Catalogue Number: C408650
• Device Lot Number: 14107371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 3.5X33MM XIENCE STENT; DRAGONFLY OPTIS IMAGING CATHETER
• Patient Sex: Unknown