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

Model Number 1014651

Device Problem Difficult to Remove (1528)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The hi-torque bmw guide wire referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca).The patient anatomy included previously implanted stents with in-stent restenosis.The dragonfly opstar imaging catheter was advanced over the balance middleweight (bmw) guide wire.The dragonfly opstar was used without issue and after imaging was performed, an attempt was made to remove; however, the bmw guidewire was also removed.The physician had not intended to remove the guidewire, and upon removal, it was noted that the end of the bmw was angulated and mangled.There was no resistance noted during removal of the dragonfly opstar and bmw guide wire, but the devices were entangled.The physician rewired the vessel with a new bmw guidewire and the procedure was continued and completed.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual analysis, additional testing methods, and dimensional analysis were performed on the returned device(s).The reported difficulty removing the catheter from the guidewire was unable to be confirmed due to the returned condition of the device (stuck on damaged guidewire); however, there was damage observed to the returned catheter which is consistent with the reported event.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 difficulty removing the catheter from the guidewire was likely related to operational context.It is likely that the guidewire being used became damaged due to operational context (patient conditions, use technique, external interactions, etc.), which then caused the difficulty removing the catheter from the guidewire.The difficulty removing the catheter from the guidewire caused the distal end of guidewire exit port to tear.While the reported withdrawal issue could not be conclusively determined, it is likely that either the patient¿s anatomical condition(s) or guidewire damage caused the reported issue.The window tube was also noted to be kinked and stretched longitudinally.The catheter was also noted to be bent at the edge of the catheter¿s distal tip.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: 17167613
• MDR Text Key: 317837226
• Report Number: 2024168-2023-06520
• Device Sequence Number: 1
• Product Code: DQO
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8982363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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