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

Catalog Number 1014652

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot history records and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The reported patient effect of vascular dissection resulting in an unexpected medical intervention is listed in the opstar instructions for use as a known potential patient effect associated with the use of the device.The reported failure to advance was determined to be related to operational context.In this case, it is likely that the failure to cross was due to patient anatomical conditions (heavy calcification).The reported dissection was caused when the guide catheter was further inserted into the coronary artery, as well as using a guide extension in attempt to pass the lesion.Based on the reported information and results of the complaint investigation there is no indication the reported failure to advance is related to a potential product quality issue.

Event Description

It was reported that the dragonfly opstar imaging catheter was to be used in the left anterior descending (lad) lesion with severe calcium.However, the imaging catheter failed to cross the lesion.The guiding catheter was manipulated more into the vessel, trying to provide more support with the guide extension; however, a dissection occurred in the left main due to the manipulation.The dissection was treated with a stent.No additional information was provided.

• 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: 19110175
• MDR Text Key: 340225135
• Report Number: 2024168-2024-04698
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031112
• UDI-Public: (01)05415067031112(17)251112(10)10063833
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K192019
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014652
• Device Lot Number: 10063833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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 Outcome(s): Required Intervention