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

Catalog Number C12059

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Communication or Transmission Problem (2896)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event estimated as (b)(6) 2023.

Event Description

It was reported that the pressurewire x wire device was inserted into an unspecified catheter prior to use.However, the device became broken and no signal was displayed.The procedure continued with a new pressurewire x wire device.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, it was reported that the pressurewire x wire device was inserted into an unspecified catheter which was inside the patient, however, the device became kinked and signal was lost between the device and the system.The device was removed and the procedure continued with a new pressurewire x wire device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported communication or transmission problem was not confirmed.During functional testing, the pressurewire was able to be connected and calibrated with a quantien system.The reported bends/kinks were confirmed.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 revealed no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported communication or transmission problem.It may be possible that an insufficient electrical contact occurred between guidewire and pwx transmitter; however, this could not be confirmed.The bends/kinks may be the result of inadvertent mishandling or interaction with the guiding catheter during advancement.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect - impact code 2645 was removed, 2199 was added.H6: medical device problem code device code 1069 was removed, 2889 added.

• 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: 18439626
• MDR Text Key: 331929465
• Report Number: 2024168-2024-00096
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180558
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C12059
• Device Lot Number: 30518G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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