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

Model Number	VAC-6000MTE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prolonged 2nd stage.2 pulls given.Kiwi came off beginning of 2nd pull.Subgaleal hematoma.
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.Clinical innovations will continue to monitor this event and send an update if additional information is obtained.

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 20612399
• Report Number: 1722684-2024-00015
• Device Sequence Number: 18124892
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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-6000MTE
• Device Lot Number: 230626
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Unknown