MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98434
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the "sterile inflation of the stomach and anchoring of the anterior wall of the stomach to the anterior wall of the abdomen under fluoroscopic control" was performed.There was a "gastric puncture and dilatation of the puncture tract on a metal guide wire.The anchors fell out when the preliminary introducer was inserted." this was "placement of a 20f gastrostomy tube.The balloon [was] inflated with 10 cc of saline." wall thickness was 3 cm." this was noted to be a simple procedure." the patient is reported to be stable.There was no reported injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30335217, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual sample from the reported event was returned for evaluation.All information reasonably known as of 14-aug-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 21 cfr 803, 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
Correction d9: date.The device history record for the reported lot number, 30335217, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample provided was evaluated confirming two of the four sutures only suture and softshell was received for this sample.The approximate measurement of suture biosyn on the base side of softshell was approximately one-half inch while on the locking clip side was approximately one inch.Clearly, there was suture damage observed, the other two sutures were reviewed, no obvious damages or breaking observed for the two suture assemblies.Root cause could not be determined.All information reasonably known as of 13-nov-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.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22815110
• Report Number: 9611594-2025-00181
• Device Sequence Number: 5713350
• Product Code: KGC
• UDI-Device Identifier: 00350770984346
• UDI-Public: (01)00350770984346(240)109843404(11)240710(17)260605(10)30335217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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 Expiration Date: 06/05/2026
• Device Model Number: 98434
• Device Catalogue Number: 98434
• Device Lot Number: 30335217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2026
• 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: 73 YR
• Patient Sex: Female