MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN PLACEMENT KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	8100-16LV
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 16 oct 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that there was an unexpected disconnection of an introducer part during a radiological percutaneous gastrostomy procedure.When removing the guidewire from the introducer, the dilator of the introducer remained inside the patient's stomach, without means to recover it.An abdominal-pelvic ct scan showed the presence of a 15cm intra-gastric foreign body.There was no immediate clinical consequence to the patient.The patient was transferred to endoscopy for removal of the foreign body.No further information provided.

• Brand Name: UNKNOWN PLACEMENT KIT
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9204338
• Report Number: 9611594-2019-00194
• Device Sequence Number: 14190578
• Product Code: KGC
• UDI-Device Identifier: 10680651442922
• UDI-Public: 10680651442922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 8100-16LV
• Device Catalogue Number: 104429200
• Device Lot Number: AA8324D18
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1