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

Model Number C408646

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty advancing and removing the catheter was unable to be confirmed; however, damage to the dragonfly catheter was noted which could be consistent with the reported event.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the difficulties were likely related to circumstances of the procedure.The stretched guide wire exit port noted on the returned dragonfly catheter suggests that the guidewire and catheter were likely spread apart after or during removal, causing the guidewire to tear into the exit port of the dragonfly resulting in difficulty removing and damage to the guidewire tip coils.While the reported withdrawal and advancing issue could not be confirmed, it is likely that either the patient¿s anatomical condition(s) or the used guide catheter size affected the delivery and withdrawal; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The bmw guide wire is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a right coronary artery (rca) with lesions along the length of the rca (59%, 67% and 70%) stenosed.There was resistance to advance the guidewire in the lesions but it was able to ultimately reach the lesion, however when deciding to remove it, resistance again with anatomy was noted.After extraction of the guide wire, the physician observed that it was "curly." there were no adverse patient effects and no clinically significant delay in the procedure.A dragonfly device was received in the return goods lab and noted the device was used and there was evidence of crystalized contrast in an on the device and in the inflation lumen.There was blood in the distal tip.The guidewire exit notch was stretched.There was no other damage noted to the device.There was evidence of crystalized contrast in an on the device and in the inflation lumen.There was blood in the distal tip.The guidewire exit notch was stretched.There was no other damage noted to the device.Additional information reported that the guide wire had resistance to advance and difficulty removing the guide wire from the dragonfly.The dragonfly catheter could be used for imaging procedure successfully.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: 14738500
• MDR Text Key: 295148969
• Report Number: 2024168-2022-06576
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8274134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Treatment: BMW GUIDE WIRE