MAUDE Adverse Event Report: ABBOTT VASCULAR C8I ¿ OCT INTEGRATED SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	C408652
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, a one hour delay occurred when two catheters could not be calibrated with the system.The error message "please adjust the calibration manually (cal-002)." appeared.The procedure was completed without oct and the patient was stable.The system was repaired to resolve the issue.
Event or Problem Description
During the procedure, a one hour delay occurred when two catheters could not be calibrated with the system.The error message "please adjust the calibration manually (cal-002)." appeared.The procedure was completed without oct and the patient was stable.The fiber contacts were cleaned and the issue was resolved.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since no component was returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: C8I ¿ OCT INTEGRATED SYSTEM
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591 ; 9519143996
• MDR Report Key: 12819311
• Report Number: 3009600098-2021-00019
• Device Sequence Number: 14678858
• Product Code: NQQ
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K188320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C408652
• Device Catalogue Number: C408652
• Device Lot Number: 7637699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown