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

Model Number	VAC-6000M
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the complaint is not confirmed because the device was not returned for evaluation and no photos were provided.Investigation description: a dhr review was performed and no deviations or ncrs were found to be initiated for lot#: 230973.Risk assessment: per fmea risk-0029 rev.02, the complaint may be associated with the following potential failure mode: potential failure mode 1: user fails to follow recommendations of abandonment; 1) if no descent (progress) of the head occurs after 2 tractions.2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.Potential effects: excessive attempts lead to fetal or maternal injury.Potential failure mode 2: user fails to establish appropriate level (450 - 600 mmhg) of vacuum.Potential effects: the device disengages/pops off the fetal head.Potential failure mode 3: user creates vacuum but fails to exclude any maternal tissue potential cause: failure to exclude any maternal tissue causes cup detachment/pop-off.Harm 1: hematoma: severity: 4.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".Harm 2: abrasion: severity: 2.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 3: fracture: severity: 3.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 4: laceration: severity: 3.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 5: death: severity: 5.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".Root cause analysis: a root cause could not be confirmed because the device was not returned for evaluation.User error and device malfunction cannot be ruled out as potential root causes.
Event or Problem Description
In customer words: "hello, we have a customer that has called me about some issues while using the kiwi.They are long time users of the product.They recently have had three babies that have had lacerations on the scalp caused by pop offs.This seems most likely caused by provider not following the vacca 5 step process.We are working on setting dates for a education workshop for the staff.We hope to have that completed in the next few weeks.My question is, should i fill out a complaint form? i have the lot number, but they discarded the kiwi (s) that were involved in the deliveries." "dr used kiwi for an operative delivery.Dr experienced a pop-off and the result of the pop-off was a laceration to the infant scalp.This happened on three different occasions with three different kiwis all from the same lot number.".

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• 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: zulmar molina ; 747 w 4170 s; murray, UT 84123
• MDR Report Key: 18624342
• Report Number: 1722684-2024-00003
• Device Sequence Number: 7509149
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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 Expiration Date: 07/13/2025
• Device Model Number: VAC-6000M
• Device Lot Number: 230973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown