MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER

Model Number X

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

It was reported that a pressurewire x - wireless (pw) device was advanced to a lesion in the left anterior descending (lad) artery with mild calcification without issue.Then a dragonfly optis imaging catheter was advanced over the pw without issue.Imaging was successfully performed.However, during removal of the imaging catheter, resistance was felt with the pw.Then the pw became separated distal to the pressure sensor.The separated portions remained in the monorail of the imaging catheter; and therefore nothing was loose in the patient.The separated portions of the pw and imaging catheter were removed as a single unit, completing the diagnostics testing.There were no adverse patient effects and 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 exception.Additionally, a review of the complaint history identified no other similar complaint reported from this lot.Based on the similar product investigation/complaint review, there is no indication of a lot specific product quality issue.The investigation determined that the reported break and difficult to remove was likely related to circumstances of the procedure.It is likely that challenging anatomy caused damage to the pressurewire or imaging catheter causing the reported issue; however, without having the device to examine, 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 dragonfly optis referenced is filed under a separate medwatch report number.

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Type of Device: CATHETER TIP PRESSURE TRANSDUCER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14469541
• MDR Text Key: 292369356
• Report Number: 2024168-2022-05492
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: X
• Device Catalogue Number: C12059
• Device Lot Number: 11126G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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
• Treatment: DRAGONFLY OPTIS IMAGING CATHETER