MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-18 INTRODUCER KIT; DH EF PERC PLACEMENT PRODUCTS

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.All information reasonably known as of 26 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).Device not returned.
Event or Problem Description
It was reported that two sutures broke three days after placement and a suture broke on the following day.The procedure was performed on (b)(6) 2017.The patient is a (b)(6) male suffering from congenital developmental disorders with an estimated height of 120cm.The patient has strong muscle contractions and visceral anomalies.During the operation, needles were obliquely punctured due to the visceral anomalies and sutures were held with forceps near body surface until the fixation could be confirmed via fluoroscopy.Per additional information received when the rep visited the hospital, a mic-key gj tube was placed.There was no additional fixation performed.The stomach is currently held only in place with the tube.The patient will stay in the hospital a few days longer than expected for observation.

• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6676392
• Report Number: 9611594-2017-00094
• Device Sequence Number: 1973068
• Product Code: KGC
• UDI-Device Identifier: 10680651984330
• UDI-Public: 10680651984330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1
• Patient Age: 25 YR