MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 14 FR; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number 8160-14

Device Problem Malposition of Device (2616)

Patient Problems Necrosis (1971); Peritonitis (2252); Fasciitis (2375); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 22-apr-2021 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.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 "the inner disc [of the peg device] was within the stomach, but the external bumper had slipped, permitting the stomach to pull away thereby producing the peritonitis, compartment syndrome and now necrotizing fasciitis." additional information received 08-apr-2021 stated the patient underwent an emergency laparotomy with replacement of the peg tube with a gastrostomy tube.The patient remained critically ill in the cardiac intensive care unit (icu) with necrotizing fasciitis and had undergone multiple surgical procedures.

Event Description

Additional information was received on 27-apr-2021 from fda medwatch report # 5100693 and the following was noted: a female underwent uncomplicated peg placement with a 14 fr avanos brand mic percutaneous endoscopic gastrostomy the patient had migration of the tube, allowing formula leakage, peritonitis, sepsis and now necrotizing fasciitis (noted via (b)(4)) we had a similar event 1 week later with the same size and brand tube without other explanatory factors on review of data, ((b)(4)) this is the 3rd tube migration with this size and brand in a 12 month period at our institution.

Manufacturer Narrative

Correction: b3, d1, d4 additional information: b5, d4, g2 and h4 the device history record for the reported lot number, 30062781, 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 24-may-2021 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 Description

Additional information received 02-sep-2021 stating follow-up with the physician noted the common cause in the case was that no pexy was done.The gastroenterologist works with a general surgeon on the procedure to perform the endoscopy and stoma creation/peg placement respectively; and importantly that pexies have never been part of our procedure.The patient was medically complicated with underlying health issues, cardiac, etc.The stoma came apart around 3-days post-operatively.The external disc never slipped but the physician felt the internal bumper was 'too floppy.'.

Manufacturer Narrative

All information reasonably known as of 23-sep-2021 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 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 14 FR
• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11711212
• MDR Text Key: 249495375
• Report Number: 3006646024-2021-00004
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770446110
• UDI-Public: 00350770446110
• Combination Product (y/n): N
• PMA/PMN Number: K924065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 8160-14
• Device Catalogue Number: N/A
• Device Lot Number: 30062781
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10