MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETYPEG KIT WITH ENFIT CONNECT- 20 FR-PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	8180-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 05-jun-2023 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported "a gastroenterologist was attempting to place a peg [percutaneous endoscopic gastrostomy] when the trocar catheter migrated into the patient¿s soft tissue, becoming irretrievable externally.In attempt to move the trocar catheter back out of the soft tissue, the physician used the gastroscope and a snare to push the trocar from inside.When they did this, the trocar broke.The trocar was then lodged in the soft tissue and unable to be retrieved endoscopically.A general surgeon was consulted, and the patient is going to the or [operating room] this morning to remove the trocar catheter from the soft tissue.The catheter was not able to be removed in the endoscopy lab.The patient was taken to the or by a general surgeon.Initially, the patient was to be taken to the or on the same day of the event, but after a computed tomography(ct) scan was performed post attempted peg placement and it was decided to take the patient to the or the previous night.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30248681, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The used sample returned was a sheath (gray hub with white sheath).The sheath exhibited to be wrinkled and bent and it was deformed.The damaged observed on the sample was most likely caused during the removal attempt/removal from the patient because its current condition would have been noticeable by the user before the procedure.The root cause of the trocar lodging in the patient¿s soft tissue of the patient¿s anatomy is undetermined at this time.All information reasonably known as of 19-jul-2023 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: MIC SAFETYPEG KIT WITH ENFIT CONNECT- 20 FR-PULL
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17064815
• Report Number: 3006646024-2023-00024
• Device Sequence Number: 14976185
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• UDI-Public: 00350770445991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 04/30/2024
• Device Model Number: 8180-20
• Device Catalogue Number: N/A
• Device Lot Number: 30248681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 101 KG