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

Model Number C408646

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 03/25/2022

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.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 cause for the reported dissection, and the relationship to the product, if any, cannot be determined.Dissection is listed in the dragonfly optis instructions for use (ifu) as a known complication that may occur as a consequence of intravascular imaging and catheterization procedures.The unexpected medical intervention, and treatment with medications were 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 the procedure was performed in a heavily calcified, heavily tortuous and 90% stenosed lesion in the left anterior descending artery.A dragonfly optis catheter was inserted but was unable to cross the lesion.It was then observed the catheter caused a dissection in the left circumflex.Therefore, the catheter was removed and a stent was implanted to treat the dissection.There was no clinically significant delay in the procedure.No additional information was provided.

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.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 cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The unexpected medical intervention were related to procedural circumstances.The reported patient effects of vascular dissection and angina are listed in the instructions for use as known complications that may occur as a consequence of intravascular imaging and catheterization procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: article, "ostial circumflex dissection caused by off-track oct catheter"a2, age g2, added report source "literature".H6, medical device problem code: code 2524 was changed to 2920; clinical codes 1710 and 1914 added.

Event Description

Subsequent to the previously filed report, additional information was received that the physician had written a case study article about this patient titled, "ostial circumflex dissection caused by off-track oct catheter".The guide catheter was repositioned to have a more coaxial engagement and the dragonfly optis catheter was successfully delivered to the distal lad, but a dissection was noted in the lcx.During oct (optical coherence tomography) evaluation, the patient was experiencing chest pain with unstable hemodynamics.Careful contrast injection revealed the above-mentioned dissection at the ostial-proximal part of lcx with compromised antegrade flow.Double-kissing culotte stenting at the left main bifurcation was performed as treatment.The patient was then stabilized.The final angiogram and 3-dimensional oct showed good results.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: 14142330
• MDR Text Key: 289512341
• Report Number: 2024168-2022-04192
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8077970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Race: Asian