MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT, ENFIT, 24 FR-PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	8180-20
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 19-sep-2024 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
Avanos medical received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the third of four reports.Refer to 3006646024-2024-00026 for the first event.Refer to 3006646024-2024-00027 for the second event.Refer to 3006646024-2024-00029 for the fourth event.It was reported during an esophagogastroduodenoscopy (egd) with placement of peg tube, there was an esophageal superficial tear visualized after pulling the peg tube over the guidewire.The physician had to place a clip to close the mucosal tear.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30297186, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2025 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.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6)2025 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
Additional information received 26-feb-2025 via medwatch/ fda user facility report mw report mw20694048 stating: "during an egd with placement of peg tube, there was an esophageal superficial tear visualized after pulling the peg tube over the guidewire.They had to place a clip to close the mucosal tear.The md reported to writer via email that this has also happened once with the same product.Writer investigated and found that the peg tube kits used in each instance were different lot numbers.This product has been used in our facility for over 2 years without any similar incidents.The product used in this instance was an avanos 20 fr mic* safety peg kit- pull method, catalog # 8180-20, lot # 30264943, exp date 2/28/2025.The md stated in his email to writer: "please see if these peg tube lot can be investigated or alternatively switched to a different brand.I have never had an issue with these in the past.My feeling is that the bumper or plastic catheter is too sharp or stiff.".

• Brand Name: MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT, ENFIT, 24 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20260054
• Report Number: 3006646024-2024-00028
• Device Sequence Number: 18114334
• Product Code: KNT
• UDI-Device Identifier: 00350770445991
• UDI-Public: (01)00350770445991(240)120007247(17)241130(10)30297186
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 11/30/2024
• Device Model Number: 8180-20
• Device Catalogue Number: 8180-20
• Device Lot Number: 30297186
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 02/26/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/10/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown