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

Catalog Number DP-SDP001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Product code: itx.Pma/510(k): k171272 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 email documents attached to this complaint were received by customer support by a woman that underwent a double mastectomy procedure in (b)(6) 2019.According to the patient her physician used a cook-swartz doppler probe for the procedure and the tip of the probe later broke off inside the patient.Additionally, the patient stated that her physician wasn¿t planning to remove the wire.Recently the woman was diagnosed with nocardia; the infectious disease doctor ordered a chest ct and brain mri.Upon her arrival for the mri, medical personnel noted the doppler wire in her and couldn¿t perform the test.Due to a recent push to obtain an mri, the patient has questions and is requesting some feedback information about the doppler probe.Her doctors are assessing options with a strong likelihood of an additional surgery to remove the wire.On (b)(6) 2021, the fragment of the doppler probe was removed from the patient.

Manufacturer Narrative

The quality assurance department performed the investigation of this doppler probe.A functional test was unable to be performed due to only wires being returned.Per customer testimony: "when i went for my post-op visit, my dr (dr.(b)(6)) was attempting to remove the wire and he was successful on the left side, but the wire broke off on the right side.He made another incision and tried to get it, but he couldn¿t.He then did some research and called some of his fellow surgeons and was told that some surgeons leave the wires in always (they don¿t even attempt to remove it post-op).We then concluded that it must be okay to leave it in.He said it may affect me getting an mri in the future, but i thought he just meant a breast mri." the device was inspected under magnification.During the visual investigation, there was blood present on the wires.On the wires there were ends that appeared to have been cut due to the visual straight end.Three wires were returned on this complaint one end of wires to have a straight edge demonstrating that they were cut, which confirms the customer complaint testimony.Per ifu (d00078672 rev003): "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." , "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." the device history record (dhr) was unable to be reviewed due to the lot being unknown.Quality control inspects the devices 100%.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: 11508010
• MDR Text Key: 253500002
• Report Number: 2522007-2021-00011
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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
• Date Manufacturer Received: 02/18/2021
• 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
• Patient Sex: Female