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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER Back to Search Results
Catalog Number C12059
Device Problems Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Event Description
It was reported that during the procedure the pressurewire x wireless device was not recognized.There were no reported adverse patient effects and no clinically significant delays in the procedure.After the initial information was reported, it was noted that the device was expired.No additional information was provided.
 
Manufacturer Narrative
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 identified no indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported communication or transmission problem.It may be possible that an insufficient electrical contact between the guidewire and pwx transmitter occurred.It may also be possible inadvertent damage due to mishandling occurred resulting in open circuit which caused the reported issue; however, without having the device to examine, this could not be confirmed.It should be noted that the pressurewire x wireless instruction for use (ifu) 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 31 december 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 the expired product caused or contributed to the reported calibration issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2017 - use after expiration.
 
Event Description
Subsequent to the initially filed report, additional information was received that the procedure date was updated to (b)(6) 2022, therefore the device was not used past the expiration date.No additional information was provided.
 
Manufacturer Narrative
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 identified no indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported communication or transmission problem.It may be possible that an insufficient electrical contact between the guidewire and pwx transmitter occurred.It may also be possible inadvertent damage due to mishandling occurred resulting in open circuit which caused 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.B3 - date of event updated.H6; medical device problem code 2017 removed.
 
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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)
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 Key17932368
MDR Text Key325629281
Report Number2024168-2023-11314
Device Sequence Number1
Product Code DXO
UDI-Device Identifier05415067025715
UDI-Public05415067025715
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K180558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
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 Date12/31/2022
Device Catalogue NumberC12059
Device Lot Number10121G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2023
Initial Date FDA Received10/13/2023
Supplement Dates Manufacturer Received10/17/2023
Supplement Dates FDA Received11/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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