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

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.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.No device was returned to cvi, therefore a physical investigation of the device could not be performed.The complaint could not be confirmed through a physical investigation.Per ifu (d00078672 rev003): "the cook-swartz doppler flow probe should only be used with the cook doppler blood flow monitor.", "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 can not be removed using gentle traction, the transducer assembly should be removed surgically.", "changes in audio signals produced by the cook doppler blood flow monitor system should be immediately documented and reported to the responsible healthcare provider.", "caution: do not remove the probe conductor wire and crystal assembly (leaving only the cuff in situ on the vessel), until vessel monitoring is completed (commonly 3-5 days).Probe conductor wire and crystal assembly placement must not exceed 29 days.Cuff alone may remain within the patient indefinitely.", "avoid the application of electrosurgical energy on or near a connected cook-swartz doppler flow probe or extension cable as damage to the monitor may occur.", "use of the cook-swartz doppler flow probe involves potential risks normally associated with any implanted device, e.G., infection, perforation or laceration of vessels, erosion, implant rejection, or device dislodgement/migration.", "device specific risks include separation of the doppler crystal from the cuff, inability to percutaneously remove the crystal after monitoring is complete, loss of reception or transmission of ultrasound monitoring signal." this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: DIAGNOSTIC 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 Key: 11360403
• MDR Text Key: 232914941
• Report Number: 2522007-2021-00009
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• 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 Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP-SDP001
• Device Lot Number: UNKNOWN
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention