MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98431
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
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 20-nov-2018 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).
Event or Problem Description
It was reported that three t-fasteners migrated to the gastric mucosa on an infant's stomach and caused pain.A gastrostomy procedure was performed on (b)(6) 2018.A laparoscope and endoscope were used for the gastrostomy with three anchors set.The inside of the stomach was deaerated by a doctor.There were no noted procedural issues.The anchors and t-fasteners remained through the middle of september.The doctor would check the inside of the stomach during next replacement of the catheter.The patient experienced pain.A ct scan was performed and it was noted three t-fasteners migrated to gastric mucosa and this was the cause of the pain.The positions of t-fastener were noted as follows: serous membrane in the stomach, inside of the peritoneum, one came out of subcutis with pain.The t-fasteners were removed at 11am on (b)(6) 2018.The clinical course is as follows: on (b)(6) 2018: the patient underwent gastrostomy using an introducer kit under endoscopic and laparoscopic guidance.The stomach and gastric wall was fixed at 3 points.On (b)(6) 2018: the patient visited outpatient department of the hospital.All the anchors were retained on the skin, so the surgeon removed the anchors.On (b)(6) 2018 the surgeon confirmed all 3 t-fasteners were stuck on the stomach.On (b)(6) 2018: the surgeon had planned to replace gastrostomy tube and check the t-fasteners were still in the stomach, but the patient¿s hospital visit was postponed due to patient¿s health condition.Unknown (b)(6) date: one of the t-fastener was out of the skin.(b)(6) 2018: the surgeon confirmed all 3 t-fasteners were not in the stomach.(b)(6) 2018: the t-fastener coming out of skin was surgically removed.The surgeon continues with patient follow-ups.However, open surgery could be required to remove the rest of the t-fasteners.The surgeon noted that the t-fastener migration was caused by the softness and thinness of the gastric mucosa.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8091046
• Report Number: 9611594-2018-00211
• Device Sequence Number: 16508741
• Product Code: KGC
• UDI-Device Identifier: 10680651984316
• UDI-Public: 10680651984316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 98431
• Device Catalogue Number: 991098431
• 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: 10/31/2018
• Initial Report FDA Received Date: 11/20/2018
• Patient Sequence Number: 1
• Patient Age: 2 YR