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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problem Failure to Disconnect (2541)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation/evaluation: reported event was confirmed via customer testimony, review of complaint history, and literature review. Actual device was not returned so physical evaluation could not be formed. Precautions identified in the instructions for use state: "to avoid use of excessive force when removing transducer assembly from the patient as it may cause injury to the blood vessel. If the transducer assembly cannot be removed using gentle traction, the transducer assembly should be removed surgically". Also included in the instructions for use are potential adverse events such as perforation or laceration of vessels and device dislodgement/migration. A review of the device history record could not be performed as no lot number was provided for the involved device. Investigation results concluded that the reported event was due to product use or handling related in operational and/or environmental context. A summary of the investigation has been sent to the complainant.
 
Manufacturer Narrative
(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
Customer reported that a patient underwent a free-flap surgical procedure. A cook-swartz doppler probe was used to monitor blood flow to the anastomotic site. The anastomotic site was damaged during planned removal of the device five (5) days following implant. A description of the damage and extent was not provided. The patient was returned to surgery for site exploration and a reanastomosis of the vessel. No further event or patient information was provided. The instructions for use (ifu) that accompany the device cautions the user to "avoid use of excessive force to remove the transducer assembly from the patient, which may cause injury to the blood vessel. If the transducer assembly cannot be removed using gentle traction, the transducer should be removed surgically. " the ifu also lists potential adverse events which include ". Separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal when monitoring is complete,. ".
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Type of DeviceITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
brian johnston
MDR Report Key6649588
MDR Text Key197201781
Report Number2522007-2017-00024
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberDP-SDP001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/19/2017 Patient Sequence Number: 1
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