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

Catalog Number	100119004
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when using the optis integrated system , an unspecified stent was to be implanted.However, the rendering stent seems to be off 10mm.The outcome of the procedure is unknown at this time.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Field service will be performed.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.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: field service was performed on the the optis integrated system, and a resolution was not provided due to the rendering stent seemed to be blood swirl which was read as a stent, but this was not confirmed.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.It may be possible that the issue was due to a software design or implementation defect, algorithm performance, or poor blood clearing.However, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: OPTIS INTEGRATED
• 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: 17959089
• Report Number: 2024168-2023-11507
• Device Sequence Number: 5282459
• Product Code: NQQ
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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 Catalogue Number: 100119004
• Device Lot Number: 15066057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/05/2024
• 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
• Patient Sex: Unknown