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

Model Number G21363

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: custom person (address line 1): (b)(6). 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

It was reported that a patient underwent a unknown procedure which involved the cook-swartz doppler flow probe standard cuff (dp-sdp001), in which an unknown portion of wire broke off during attempted removal of the device. The malfunction was not obvious to the provider who removed the device. The fragment of wire remaining in the patient was discovered several days later and remains in the patient, based on the information provided to the manufacturer. Additional information has been requested from the user facility regarding the patient outcome and device malfunction.

• 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: 11304624
• MDR Text Key: 246297746
• Report Number: 2522007-2021-00003
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N172688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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: 02/09/2021 Patient Sequence Number: 1