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

Model Number C408646

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of the dragonfly catheter, when purging contrast through the side port, it was thought there was a perforation distal to the lens.A new dragonfly was used to complete the procedure.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual analysis and functional testing were performed on the returned device.The reported leak and catheter damage (perforation or tear in sheath) issue was unable to be confirmed, as the device functioned as intended.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 leak and catheter damage (tear or perforation in catheter sheath) could not be confirmed, as the device functioned as intended.It may be possible that customer is unaware of the optis and opstar models both having a designated purge hole, which is distal to the lens and proximal to the guidewire exit port, and differs from previous dragonfly models that have purged liquid exit through the guidewire exit notch/port; however, 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.D4: correction lot# from unknown to 8436616.

• 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: 15239710
• MDR Text Key: 302711387
• Report Number: 2024168-2022-08819
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8436616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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