MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number C408646

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported the dragonfly optis imaging catheter is apparently too long compared to other probes.The distance between the markers do not comply with the official technical sheet.The distance between the proximal marker of the probe and the tip of the probe measures 87mm.According to the product description, this length is supposed to be 77mm.This difference is probably due to the length which separates the marker from the lens to the marker distal to the probe which should normally measure 23mm but measures 33mm on this probe.This resulted in the inability to perform a run on the lesion.The probe being too long, according to the cardiologist, bumps into the distal artery and does not allow the lens to cover the entire lesion.A run was not performed and therefore a pullback was not performed; the lens did not move voluntarily or involuntarily.Optical coherence tomography with this probe was not possible.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported defective device (marker band incorrect location) was unable to be confirmed due to the device condition (stretched sheath); however, there marker bands were appropriately fixed in their expected respective position(s).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the reported difficulty was due to operational context.The stretched guidewire exit port noted on the returned dragonfly catheter suggests that catheter was likely inserted onto a guidewire and then withdrawn prior to return.The returned condition of the devices suggests that there was resistance encountered during removal from the guidewire/guide catheter, which would cause the window tube and guidewire exit notch distal edge to stretch longitudinally in the distal direction, resulting in the reported marker band distance issue.While the lens marker was more proximally located than specified on the instructions for use (ifu), the cause was a combination of the sheath stretching, the expected use, and the varied nature of the lens location.It should be noted that the value shown on the ifu are not manufacturing prints and are to be used for use reference and not product quality/functionality.The lens marker of the catheter is able to move proximally within the sheath during use, so the value provided on the ifu with respect to the lens marker will expectedly change/vary depending on use state.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4 - lot number was corrected from 9032875 to 8868160.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• 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: 17470423
• MDR Text Key: 321067055
• Report Number: 2024168-2023-08501
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: C408646
• Device Lot Number: 8868160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1