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

Model Number	C408646
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
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 during preparation with the dragonfly optis imaging catheter, while inserting the guidewire into the imaging catheter, the distal tip separated into two pieces.Therefore, the imaging catheter was not used in the patient and an unknown device was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial emdr report, the following information was provided: it was reported during use with the dragonfly optis imaging catheter, while inserting the guidewire into the imaging catheter, the distal tip separated into two pieces.Therefore, the imaging catheter was removed the patient and an unknown device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis and functional testing were performed on the returned device.The reported separation was not able to be confirmed, as the returned device was without any separation or related damage noted.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 investigation was unable to determine a cause for the reported material separation.The returned catheter was confirmed to have remained intact and without any separation.In this case, it may be that the user assumed the sheath damage (kinked sheath throughout and stretched guidewire exit notch; however, there was no material separation observed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated.D1: correction (brand name updated).D2a: correction (common device name updated).D3: correction (manufacturer name, address, city, state and postal code updated).E1: first, last name updated from unknown to (b)(6).E1: title updated from dr.To ms.E3: occupation updated from physician to pharmacist.H6 - removed 2645 and added 2199.

• Brand Name: DRAGONFLY¿ OPTIS¿
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886 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: 19499409
• Report Number: 2024168-2024-06763
• Device Sequence Number: 17845504
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250717(10)9139998
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141769
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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 Expiration Date: 07/17/2025
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 9139998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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