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

Model Number 1014651

Device Problems Calibration Problem (2890); Gas/Air Leak (2946)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the dragonfly catheter was being prepared; however, the error cal-002 was noted on the screen and it would not connect to the doc.Additionally, when purging the catheter air was coming into the syringe, indicating a leak somewhere.The procedure was successfully completed with another dragonfly catheter.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

Visual analysis and additional testing methods were performed on the returned device.The reported calibration issue and gas leak were unable to be functionally tested due to the dried contrast within the sheath preventing functional testing.However, an optical fiber integrity test revealed an optical fiber break located in the proximal region of the catheter.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents reported from this lot.The investigation determined that the reported calibration issue was related to the circumstances of the procedure; however the reported issue of air entering the syringe was unable to be confirmed.Based on the evaluation of the returned device, the reported calibration issue appears to be due to the noted optical fiber fracture.It is likely that the catheter shaft had been inadvertently kinked/bent during preparation/use, which caused damage to the optical fiber and resulted in the reported calibration issue.It may be possible that for the reported air entering the syringe, that improper syringe preparation occurred such as retraction of the syringe plunger during preparation causing vacuum within the syringe and the catheter (not intended use).It may also be possible inadvertent rupture/damage occurred causing air to enter the device; however, this could not be confirmed as there were no observed damages/ruptures to the returned catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: DRAGONFLY OPSTAR¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC IMAGING 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: 14880601
• MDR Text Key: 295900672
• Report Number: 2024168-2022-07093
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: 05415067031129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192019
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8171373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2021
• 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