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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE
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ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE Back to Search Results
Catalog Number UNK HT COMMAND 18
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/04/2024
Event Type  Injury  
Manufacturer Narrative
B3: date of procedure estimated as (b)(6) 2024.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that the command 18 guidewire got uncovered when removing it from the patient.No additional information was provided.
 
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Brand Name
HI-TORQUE COMMAND 18 GUIDE WIRE
Type of Device
GUIDE WIRE
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005737652
road no.2 km 58.0 cruce dávila
barceloneta PR 00617
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key18977379
MDR Text Key338559931
Report Number2024168-2024-03643
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K152404
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
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HT COMMAND 18
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/05/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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