MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-16 INTRODUCER KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	98432
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for aa6228r06 was reviewed and the product was produced according to product specifications.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).Not returned to manufacturer.
Event or Problem Description
It was reported that a dilator became stuck inside the peel off catheter during placement.The dilator remained inside the abdomen, and got pushed inside the stomach when the tube was placed.A surgical procedure was required to remove the dilator piece.No further information has been received at this time.

• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6343866
• Report Number: 9611594-2017-00024
• Device Sequence Number: 925458
• Product Code: KGC
• UDI-Device Identifier: 10680651984323
• UDI-Public: 10680651984323
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2017

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: 07/01/2018
• Device Model Number: 98432
• Device Catalogue Number: 991098432
• Device Lot Number: AA6228R06
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention