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.

• 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

• 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 Treatment Data

Date Received: 03/17/2021 Patient Sequence Number: 1