MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. DRAGONFLY OPSTAR¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	200-700-00
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
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
It was reported that the dragonfly opstar's drive optical connecter (doc) cover was found to be unsealed during preparation.Therefore, the doc cover was not used in the patient.A dragonfly optis imaging catheter with a sterile doc cover was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis methods were performed on the returned device.The reported packaging issue (incomplete/compromised seal) was confirmed.Lot history record (lhr) and corrective and preventive 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.The returned doc cover pouch was returned and confirmed to be missing the bottom portion of the perimeter seal.The doc cover not being completely sealed was determined to be a potential product quality issue; therefore, exception issue has been initiated to further evaluate this complaint.Exception issue has been initiated due to the potential product quality issue and corrective action, if any, will be determined per internal operating procedures.

• Brand Name: DRAGONFLY OPSTAR¿
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• 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: 20098287
• Report Number: 2024168-2024-10246
• Device Sequence Number: 18110288
• Product Code: DQO
• UDI-Device Identifier: 10618125188632
• UDI-Public: (01)10618125188632(17)261008(10)034579
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192019
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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 Model Number: 200-700-00
• Device Catalogue Number: 200-700-00
• Device Lot Number: 034579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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