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

Catalog Number C408641

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 indication of a lot specific product quality issue.The reported patient effect of vascular dissection is listed in the dragonfly optis instruction for use, as a known complication that may occur as a consequence of intravascular imaging and catheterization procedures.The investigation determined that the reported failure to advance was related to circumstances of the procedure.It is likely that anatomical challenges prevented the imaging catheter from crossing the lesion.It is also likely that the reported applied excessive force during an attempt to cross the lesion caused a vascular dissection.The unexpected medical intervention was related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that a dissection was noted after strong force was used with the dragonfly optis catheter that was unable to cross the moderately tortuous, heavily calcified, chronic total occlusion in the left anterior descending coronary artery.The cause of the dissection was unknown.The dragonfly optis catheter was unable to cross due to the patient anatomy.Prolonged balloon inflation was used to treat the dissection.Intravascular ultrasound (ivus) was performed instead of oct imaging.The procedure was completed with no further issues and the patient was stable.There was little delay in the procedure.No additional information was provided.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR 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: 17644964
• MDR Text Key: 322211901
• Report Number: 2024168-2023-09437
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C408641
• Device Lot Number: 8964612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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