MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-12 INTRODUCER KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	98430
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided 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 (b)(4).Device not returned.
Event or Problem Description
It was reported that three to four weeks following placement of the sutures, the external bumpers fell off normally but the internal anchors remained in place and caused pain.Surgery was required to remove the anchors.No further information has been provided 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: 6299597
• Report Number: 9611594-2017-00018
• Device Sequence Number: 16523475
• Product Code: KGC
• UDI-Device Identifier: 10680651984309
• UDI-Public: 10680651984309
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 01/15/2017

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 Model Number: 98430
• Device Catalogue Number: 991098430
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2017
• Initial Report FDA Received Date: 02/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Weight: 3