MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-20 INTRODUCER KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	98434-17
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Perforation (2001)
Date of Event	09/16/2016
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 aa6032r03 was reviewed and the product was produced according to product specifications.The patient died following using a medical product, but there was no suspected association between the death and the use of the product all information reasonably known as of 24 apr 2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that after receiving a gastrostomy on (b)(6) 2016, the patient experienced high fever and abdominal pain.X ray on (b)(6) 2016 showed free gas.An exploratory laparotomy was performed, and an anchor suture from the gastrostomy procedure was found perforating the stomach wall.The perforation was sewn over and the patient recovered from the surgery.The patient later died as a result of their cancer.The type of cancer was not reported.No further information has been provided.
Additional Manufacturer Narrative
All information reasonably known as of 21 jun 2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6521215
• Report Number: 9611594-2017-00070
• Device Sequence Number: 16476548
• Product Code: KGC
• UDI-Device Identifier: 10680651984347
• UDI-Public: 10680651984347
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: 98434-17
• Device Catalogue Number: 991098434
• Device Lot Number: AA6032R03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention