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

Model Number	X
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressurewire x could not be calibrated despite multiple attempts.The light was flashing green on the transmitter.Restarting the system and re-inserting the wire in the cable box did not resolve the issue.No patient was involved.The percutaneous coronary interventional procedure was completed without fractional flow reserve.No additional information was provided.Abbott vascular identified that this device expired (b)(6) 2022.Although no patient was involved, this device was intended to be used in the patient after the labeled expiration date.
Additional Manufacturer Narrative
(b)(4).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 revealed no similar complaints reported from this lot.It should be noted that the pressurewire x cable connection instruction for use references the ¿use by¿ date symbol which is available on the product label to indicate the product expiration date.The expiration date for this device was (b)(6) 2022 and it was attempted to be used on (b)(6) 2022.The expiration date of the product is important for the sterility, efficacy, and performance of the device.It could not be determined if attempting to use the expired product caused or contributed to the reported calibration issue.The investigation was unable to determine a cause for the reported communication or transmission problem (signal calibration failure).It may be possible that an insufficient electrical contact between the guidewire and pwx transmitter occurred; 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.

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Common Device Name: CATHETER TIP PRESSURE TRANSDUCER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14551618
• Report Number: 2024168-2022-05801
• Device Sequence Number: 4919973
• Product Code: DXO
• UDI-Device Identifier: 05415067025739
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: X
• Device Catalogue Number: C12009
• Device Lot Number: 7492303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown