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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER

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COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER Back to Search Results
Catalog Number DP-SDP001
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Embolus (1830); Embolism/Embolus (4438)
Event Type  malfunction  
Manufacturer Narrative
Product code: itx. Pma/510(k): k171272. (b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
The literature finding specifies that a patient underwent an unknown procedure which involved the cook-swartz doppler flow probe standard cuff (dp-sdp001), in which there was a loss of venous signal. An exploration surgery was performed on the patient where it was noted that a fat lobule, which was routinely added within the sleeve of the probe to prevent rotation, had a large clot formed around it. The clot was removed and the signal returned. There were no further complications reported. The authors suggest that the complication is due to their method of coiling the wire loop under the skin, which is not a standard practice. This practice is also not recommended by the manufacturer.
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Type of DeviceDIAGNOSTIC ULTRASONIC TRANSDUCER
Manufacturer (Section D)
COOK VANDERGRIFT INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer (Section G)
COOK VANDERGRIFT INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
brian johnston
1186 montgomery lane
vandergrift, PA 15690
7248458621
MDR Report Key11349993
MDR Text Key267691928
Report Number2522007-2021-00006
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDP-SDP001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1
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