MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PUSH OTW; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7170-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was "a peg tube break upon removal with traction from patient." the peg broke below the skin level when attempting to remove.The clinicians brought the patient over to sedate and perform an egd, however, the clinicians were unable to pass the scope due to advanced cancer.The patent was having a surgery consultation in order to remove the remnant and place a replacement tube for future use.Additional information received 19-aug-2021 stated the peg was placed on (b)(6) 2020.The device broke during traction removal on (b)(6) 2021 and went to the operating room (or) afterward (b)(6) 2021.The underwent an exploratory laparotomy, gastrostomy, removal of foreign body, gastrostomy closure, and g-tube replacement.The patient was discharged from the hospital on (b)(6) 2021.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 07-sep-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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, inc.Complaint database and identified as complaint (b)(4).

• Brand Name: MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PUSH OTW
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12436631
• Report Number: 3006646024-2021-00017
• Device Sequence Number: 16992253
• Product Code: KNT
• UDI-Device Identifier: 00350770409788
• UDI-Public: 00350770409788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 7170-20
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 08/13/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR