MAUDE Adverse Event Report: HALYARD HEALTH MIC* PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	7160-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for 0202691837 was reviewed and the product was produced according to product specifications.All information reasonably known as of 13 feb 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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
It was reported that the patient sustained an esophageal tear from the device bumper during peg tube placement.Two clips were placed to stop the bleeding.No further medical intervention was performed.The tube had been lubricated prior to placement.The procedure was completed, and the patient is stable and the peg tube is working without issue.The patient had no history of esophageal stricture, narrowing, or varices.The physician did not report seeing anything abnormal during tube placement.The customer reported that "the patient was older, so tissue is not as viable." the peg tube was placed due to the patient being unable to take anything by mouth.The patient was a female in her 80s, weight unknown.No further information has been provided.

• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7284003
• Report Number: 3006646024-2018-00002
• Device Sequence Number: 19116006
• Product Code: KNT
• UDI-Device Identifier: 10680651409772
• UDI-Public: 10680651409772
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: 7160-20
• Device Catalogue Number: 104097700
• Device Lot Number: 0202691837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other