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

Model Number C408646

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/20/2021

Event Type  malfunction  

Event Description

During the final pullback, a contrast leak occurred near the proximal hub while purging the catheter.The procedure was completed with a pullback with a new catheter with no adverse patient consequences.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that a leak was noted in the proximal region of the sheath, which is consistent with the reported event.Further investigation revealed that the sheath appeared to have a rupture, resulting in a gap, from which the aforementioned leak was noted.The cause of the leak is consistent with the sheath damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received and the condition of the returned device, the cause of the sheath damage remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591 ; 9519143996
• MDR Report Key: 13319829
• MDR Text Key: 287331428
• Report Number: 3009600098-2022-00003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141453
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7981045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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