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

Catalog Number 1014651

Device Problems Material Too Soft/Flexible (4007); Material Split, Cut or Torn (4008)

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

Event Date 07/05/2023

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 that the dragonfly opstar imaging catheter was used in a long lesion in the circumflex (cx) artery with heavy calcification.However, upon catheter removal, a tear in the guide wire exit notch was suspected because the catheter was moving on its own without the wire and not tracking.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection and dimensional analysis were performed on the returned device.The reported material split, cut, or torn and material too soft/flexible (support) were unable to be confirmed.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 identified no other similar complaints were reported from this lot.Based on the information provided and analysis of the returned device, the cause of the reported material too soft/flexible (support) and alleged tear was unable to be confirmed.There were no anomalies on the catheter which could be directly attributed to the alleged torn sheath, nor for the reported material too soft/flexible (support).It is likely that either the patient¿s anatomical condition (heavy calcification) or use techniques caused the reported difficulties; 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.

• 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: 17401216
• MDR Text Key: 319896773
• Report Number: 2024168-2023-08083
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014651
• Device Lot Number: 9052840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male