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

Catalog Number DP-SDP001

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

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

The literature finding specifies that a patient underwent a unknown procedure which involved the cook-swartz doppler flow probe standard cuff (dp-sdp001).The wire of the device was removed on post-operative day ten.Swelling of the patient's neck was noted six hours after the removal of the device wire, so the patient was immediately taken for surgery.It was noted that there was a fresh laceration at the venous pedicle, which was immediately repaired with good results.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.The device was not returned to cvi, therefore a physical investigation could not be performed.The device history record (dhr) could not be reviewed due to the lot was not provided.This complaint will be monitored, tracked/trended through the cvi complaint handling and post market surveillance processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.Per ifu (d00078672 rev003): "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." , "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." , "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." , "to remove the cook-swartz doppler flow probe, first free the retention tab and braided wires to the skin by cutting the sutures (and/or removing the tape).Remove the probe by applying gentle traction to the braided wires at the skin entry site until the transducer assembly is withdrawn.(the silicone cuff remains in situ.)" and "upon removal of the cook-swartz doppler flow probe, examine the distal tip of the probe to ensure that the transducer assembly is present.In the unlikely event that the transducer assembly has become detached and remains in the cuff in the patient, the transducer assembly should be removed surgically." 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: 11349912
• MDR Text Key: 267693937
• Report Number: 2522007-2021-00005
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• 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 Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 01/25/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention