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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 11/20/2023
Event Type  malfunction  
Event Description
It was reported that physician had connection problem with the pressure wire x device.The procedure was completed successfully with a new pressurewire x.There was adverse patient effect and no clinically significant delay in the procedure.Based on the returned device analysis, the device was expired and used after expiration date.No additional information was provided.
 
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: 2017 device code clarifier- use after expiration.
 
Manufacturer Narrative
Visual analysis was performed on the returned device.The reported communication or transmission problem was unable to be confirmed due to the condition of the returned unit.Functional testing could not be performed as the pressurewire corewire, and microcables were separated 39 cm distal to the proximal tip.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.Based on the reported information and analysis of the returned pressurewire, the reported connection issue appears to be due to operational context.It is likely that during use, damage to the microcables occurred due to a kink resulting in the reported communication problem.The noted separations likely occurred at the kink due to post-use handling/packaging the device for return.It was determined that the pressurewire was used after expiration of 4/30/2022.The procedure date was (b)(6) 2023; therefore, the device was used approximately 19 months after expiration.The pressurewire instructions 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 of the product is important for the sterility, efficacy, and performance of the device.In this case, it could not be determined if the reported event was a result of the product being used past the expiration date.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that physician had connection problem with the pressure wire x device.The procedure was completed successfully with a new pressurewire x.There was adverse patient effect and no clinically significant delay in the procedure.Based on the returned device, the lot number was expired and used after expiration date.No additional information was provided.
 
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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 Key18581932
MDR Text Key334189348
Report Number2024168-2024-01109
Device Sequence Number1
Product Code DXO
UDI-Device Identifier05415067025715
UDI-Public05415067025715
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K180558
Number of Events Reported1
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 02/22/2024
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 Date04/30/2022
Device Catalogue NumberC12059
Device Lot Number00506G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2024
Initial Date FDA Received01/25/2024
Supplement Dates Manufacturer Received01/30/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2020
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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