MAUDE Adverse Event Report: HALYARD HEALTH GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY* T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number 98701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 08nov2017 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 Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 9611594-2017-00144 for the first patient.It was reported by the customer that "we have seen two patients at our hospital with reportable skin injuries related to this type of system.These percutaneous endoscopic gastrostomy tube securing devices are being utilized by our interventional radiologists for patients who need feed tubes." additional information was received on 17-oct-2017 by the customer states two patients have developed full thickness wounds from the t-fasteners.Additional information was requested but not received.

Manufacturer Narrative

All information reasonably known as of 11dec2017 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 (b)(4).

Event Description

Additional information was received that states, "i am having difficulty obtaining the information you require in this report.This product is placed in interventional radiology at our facility and is not followed by the provider after it is placed.I will try to locate their procedure notes for these two cases.The photo documentation looks like it could be two different products, though i¿m not certain.I will research these charts and get back to you." additional information requested but was not received.No additional information provided.

• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industrial no 40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7010934
• MDR Text Key: 91382792
• Report Number: 9611594-2017-00145
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10680651987010
• UDI-Public: 10680651987010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 98701
• Device Catalogue Number: 991098701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1