MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - OTW; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number 0630-20J

Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problems Inflammation (1932); Laceration(s) of Esophagus (2398)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.Photos of the device were provided by the customer.All information reasonably known as of 14 sep 2020 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 that the peg tube was replaced on (b)(6) 2020.When fastening the tube with snare while removing it with an endoscope, the tube was torn off.Because of that, the patient's esophagus was damaged while removing the tube and the patient had to be hospitalized.It was noted that the device was cut incorrectly while removing the tube.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Photos of the device were provided by the customer and confirmed the reported event; however, root cause could not be determined.All information reasonably known as of 03 dec 2020 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.

Manufacturer Narrative

Additional information: a2, a3, a4, b5.Corrected data: d10 all information reasonably known as of 05 oct 2020 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 comp-jhc-20-00336.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 15-sep-2020 indicated the incident occurred (b)(6) 2020 and on (b)(6) 2020 the "patient's respiratory condition turned for the worse in the evening.Systemic inflammatory reaction increased.Antibiotic medication treatment was started.[the patient's] schedule for leaving the hospital was postponed.(b)(6) 2020 antibiotic medication treatment was ongoing.Spo2 92-95%.It is suspected that the patient's respiratory condition turned for the worse because of her basal disease." no information was available regarding medical treatment for the esophageal damage.The actual sample was discarded.

• Brand Name: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - OTW
• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10537847
• MDR Text Key: 207147579
• Report Number: 9611594-2020-00184
• Device Sequence Number: 1
• Product Code: KNT
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0630-20J
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 29