MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL FETAL SPIRAL ELECTRODE SINGLE HELIX; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Model Number	31479549
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer admitted for elective induction due to coccyx pain.Once epidural was placed and provider had difficulty placing fetal scalp electrode (fse) due to concern for the fetal position.Ultrasound was used revealing vertex presentation.It was then recognized that the baby was high and in a breech position and meconium was noted.Customer had monitors removed to go to or for a stat c-section due to baby's presentation.The fse was not tracing and was cut before the c-section and part of it not removed due to the rush to the or.Post procedure xray obtained and findings per radiologist were "curvilinear foreign body with a length/bpd appearance in the midline lower pelvis and to the right of midline in lower pelvis".Radiologist was not aware of what they were supposed to be looking for and the image was not available for the ob providers to view prior to the xray tech leaving the or.Due to the fact the c-section was completed in a very quick manner, there were no counts done prior to the procedure.The radiologist did call the or with results of a not obvious sponge or instruments in the abdomen.He did note a spiral like device running across the patient which was identified as the bovie.24 hours later, a resident md was notified by nurse that patient found fse string hanging from her vagina.On exam, red and green cord was visualized hanging 2-3 cm outside of vagina.The free end of the fse cord was manually unraveled and freed from the posterior vaginal wall and the patient was given oxycodone for pain control.

• Brand Name: KENDALL FETAL SPIRAL ELECTRODE SINGLE HELIX
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 777 west st.; mansfield MA 02048
• MDR Report Key: 16706726
• Report Number: 16706726
• Device Sequence Number: 14882904
• Product Code: HGP
• UDI-Device Identifier: 10192253040500
• UDI-Public: 10192253040500
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2023
• Report Date (Section F): 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 31479549
• Device Catalogue Number: 31479549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White
• Date Report Sent to FDA: 04/03/2023