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

Model Number C408646

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) artery.The dragonfly optis imaging catheter was advanced for pre-percutaneous coronary intervention (pci).Some resistance was noted during advancement, due to the patient anatomy; however, the dragonfly optis was able to cross to the target lesion.After imaging was performed, a small dissection was noted, believed to be caused by the dragonfly optis imaging catheter.The dissection was treated with stenting.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of vascular dissection is listed in the instructions for use (ifu) df optis ous as a known complication that may occur as a consequence of intravascular imaging and catheterization procedures.Based on the information provided, the reported difficulty advancing appears to be due to circumstances of the procedure.It is likely that challenging anatomical conditions caused resistance during advancement resulting in the reported issue.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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.

• 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: 14079498
• MDR Text Key: 289215327
• Report Number: 2024168-2022-03902
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141769
• 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,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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