MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RETENTION DOME; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000793
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the guidewire in the peg kit was frayed.The device was not used on the patient.A new kit was opened to complete the procedure.
Event or Problem Description
It was reported that the guidewire in the peg kit was frayed.The device was not used on the patient.A new kit was opened to complete the procedure.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one ponsky peg 20f non-safety kit with push guidewire was returned for evaluation.It was noted that the outer core wire was unraveled and stretched with the distal ends of both inner core wires protruding from it.Based on these findings, the investigation is confirmed for the reported frayed guidewire.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the reported event.Possible contributing factors include attempted removal of guidewire from hoop before removing the retaining plug from the hoop and rapid/forceful removal of guidewire from hoop.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: BARD DELUXE GUIDEWIRE PEG SYSTEM 20F WITH SOFT SILICONE RETENTION DOME
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7950147
• Report Number: 3006260740-2018-02833
• Device Sequence Number: 940753
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 000793
• Device Catalogue Number: 000793
• Device Lot Number: HUBY1015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1