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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 Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)
Event Type  Injury  
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
As reported to customer relations via complaint form "we have had many wires break off when pulling them out over the past few months. We typically pull the wires on pod5-7 and did not have issues but recently, they are extremely hard to pull out and break off proximal to the doppler itself. This led to a practice change that the wire would be cut with a tail external to the patient and pulled out two weeks later in clinic. The hospital required another practice change as they considered that a retained foreign body. Therefore, my partner pulled this one and again, had significant resistance and the wire broke. This caused an arterial injury on an otherwise viable flap on pod 5-7. The flap ultimately required revision twice and has now failed. There is no doubt it was related to the trauma caused by the wire. ".
 
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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 Key11360403
MDR Text Key232914941
Report Number2522007-2021-00009
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberDP-SDP001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 02/22/2021 Patient Sequence Number: 1
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