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

Catalog Number UNK DRAGONFLY OPTIS

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915)

Patient Problems Ischemia (1942); Tachycardia (2095)

Event Date 11/15/2018

Event Type  Death  

Event Description

The following was reported via an article titled, "stuck oct catheter; an unanticipated complication" regarding optical coherence tomography (oct).Guided percutaneous coronary intervention was performed in the calcified left anterior descending (lad) coronary artery.Three overlapping stents were implanted in the lad.During removal of the oct catheter, it became stuck in the lad.Attempts to remove the oct catheter using intravenous nitroglycerin and insertion of a second guidewire were not successful.The guidewire could not get past the first stent overlap.It was then noted that the proximal and middle stents were damaged.The article further stated that as the distal tip of the oct catheter got stuck, its forceful tugging led to the lad stent deformation proximally across the overlap between the proximal and middle stents.Slow flow in the lad led to a ventricular tachycardic storm and the patient expired on the table.Additional information was received that this event occurred on (b)(6) 2018.According to the physician, the slow flow that occurred prior to the fatal arrhythmia was likely due to the stent deformity.Additionally, the physician reported that the oct catheter became stuck in the deformed overlapping stent.Although in the physician's opinion, the oct catheter did not cause or contribute to the patient death, this will remain a death report as the oct catheter resulted in damage to the stent, which led to the cascading adverse patient effects.No additional information was provided.

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.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 part and lot numbers were not reported.Based on the information provided in the article, the reported entrapment of device and damage caused to another device appear to be due to circumstances of the procedure.It is likely that the dragonfly catheter became caught within the three overlapping stents in the lad, of which were described to be deformed.Additionally, as the distal tip of the oct catheter got stuck, forceful tugging led to the lad stent deformation proximally across the overlap between the proximal and middle stents.The reported patient effects of ischemia, abnormal heart rhythm, and death are listed in the dragonfly optis instruction for use as known complications that may occur as a consequence of intravascular imaging and catheterization procedures.A cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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.Literature attachment: article titled : stuck oct catheter: an unanticipated complication.

• Brand Name: DRAGONFLY¿ OPTIS¿ 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: 13807213
• MDR Text Key: 287392420
• Report Number: 2024168-2022-02806
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K192019
• 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
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DRAGONFLY OPTIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG