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

Model Number C408645

Device Problems Poor Quality Image (1408); Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the dragonfly optis imaging catheter could not be retracted, resulting in an incorrect image.The imaging catheter was ultimately removed normally.The procedure was completed with another imaging catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following correction was made: it was reported that the dragonfly optis imaging catheter could not retract for pullback, resulting in an incorrect image.Due to the activation failure, the imaging catheter was removed.No additional information was provided.

Manufacturer Narrative

Visual analysis and additional testing were performed on the returned device.The reported pullback issue and imaging issue was unable to be confirmed due to the device condition; however, damage to the optical fiber of the catheter was observed which can cause/contribute to imaging/pullback issues.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.Based on the information provided and analysis of the returned device, the reported pullback issue and imaging issue were likely due to operational context.Optical fiber damage was revealed during testing, which can contribute to imaging/pullback issues.It is likely that while advancing into the anatomy inadvertent optical fiber damage occurred, which caused the poor imaging and subsequent pullback issues upon attempt; however, these conditions could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code 1528 was removed and code 3270 was added.

• 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: 15157881
• MDR Text Key: 298211189
• Report Number: 2024168-2022-08512
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 7990187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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