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U.S. Department of Health and Human Services

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

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98431
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Type  malfunction  
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 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.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR
Type of DeviceDH 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 84048
MX 84048
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta 30004
4704485444
MDR Report Key8091046
MDR Text Key129310412
Report Number9611594-2018-00211
Device Sequence Number1
Product Code KGC
UDI-Device Identifier10680651984316
UDI-Public10680651984316
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98431
Device Catalogue Number991098431
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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