MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-16 INTRODUCER KIT; DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Model Number	98432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.(b)(4) 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 (b)(4) complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(4) product is defective or caused serious injury.Device not returned.
Event or Problem Description
It was reported that, the dilator fell apart and broke off in the patient during use and was retained in the patient's stomach.The gastro-intestinal (gi) team was called and procedure was performed to snare the device via the patient's throat.No further information was provided at this time.
Additional Manufacturer Narrative
The device history record for the lot number, aa6249r02, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.All information reasonably known as of 05apr2017 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
The following fda user facility report was received for (b)(4) with an alert date: 15-feb-2017."tube was place successfully utilizing the halyard introducer kit for gastrostomy feeding tube.A post procedure c-arm ct noted a filling defect within the gastric body lying somewhat transversely which appeared to be a broken portion of the dilator contained in the kit.A loop and tri-lobed snare and ng were used to grasp the fragment and gently retract it into the esophagus without difficulty.In the upper esophagus, the loop snare became disengaged and repeated attempts could not capture the cranial end of the dilator in the upper esophagus.Under direct visualization through an endoscope, the dilator portion was entirely retrieved." the date of event was updated to (b)(6) 2017.No additional information was provided.

• Common Device Name: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6298584
• Report Number: 9611594-2017-00016
• Device Sequence Number: 1518170
• Product Code: KGC
• UDI-Device Identifier: 10680651984323
• UDI-Public: 10680651984323
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: Other Health Care Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: 98432
• Device Catalogue Number: 991098432
• Device Lot Number: AA6249R02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/11/2017
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 67