MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI VACUUM DELIVERY SYSTEM; FETAL VACUUM EXTRACTOR

Model Number	VAC-6000S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subgaleal (2603)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subgaleal hemorrhage, a bleed that occurs between the scalp aponeurosis and the periosteum of the cranial bones is a known risk of any vacuum delivery.The literature reports an incidence of 1-4% of all vacuum deliveries.These bleeds have also been known to occur in infants delivered by forceps and rarely after spontaneous deliveries.They are more likely to occur with fetal hypoxia and underlying bleeding disorders, as well as after complicated deliveries.Last update received from the user facility was that the infant was discharged without further sequela or complications.Clinical innovations will continue to monitor this event and send an update if additional information is obtained.
Event or Problem Description
First time mom spontaneous labor.No indication listed in delivery note for vacuum delivery, but baby was reported to have a non-reassuring fetal heart rate tracing.No mention of position or station at the time of delivery.Experienced clinician, but not with kiwi.Procup was used, unknown lot number (cup was not retained).No mention of pulls or pop-offs in delivery chart but was reported to be an "easy delivery".Again 2nd day noted increased head swelling.Ct showed subgaleal hemorrhage.Baby transferred to nicu and stabilized.Is doing well without sequelae and will be discharged tomorrow.

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 9335765
• Report Number: 1722684-2019-00018
• Device Sequence Number: 1849334
• Product Code: HDB
• UDI-Device Identifier: 00814247020666
• UDI-Public: 00814247020666
• Combination Product (Y/N): N
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VAC-6000S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization