MAUDE Adverse Event Report: HALYARD HEALTH INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Organ Dehiscence (2502)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa6351r01, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 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).The device was note returned.
Event or Problem Description
It was reported that the suture broke and 2 anchors came off in 2-days after placement.An additional procedure to repair and secure the stomach to the abdominal wall was performed with a funada-kit under local anesthesia.There was no reported patient injury.The doctor noted that the incision was small and it was difficult to peel dilator off, "so there may have been extra force applied in dilation process." no additional information was provided in regards to the patient's status and the outcome of the procedure.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7151191
• Report Number: 9611594-2017-00171
• Device Sequence Number: 11056196
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: Physician
• Device Expiration Date: 10/01/2018
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: AA6351R01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention