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 Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the guidewire got stuck in the "blue holder" and when pulled, it stretched, causing the front end to become very thin and floppy.A second kit was opened to finish the procedure.There was no reported patient harm.
Event or Problem Description
It was reported the guide wire allegedly got stuck in the blue feeder.It was further reported that when the guide wire was pulled it had stretched and caused the front end to become thin and floppy.It was further reported that a second kit was opened and the procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
It was also identified that the fda rn number was incorrect and the correct fda rn number (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.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.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 investigation summary: one ptfe-coated guide wire was returned for evaluation.It was noted that the outer coil wire was unraveled and stretched in multiple places with the distal end of the inner core wire broken from the guide wire and protruding through the outer coil wire.The investigation is confirmed for the reported frayed guide wire.Per the evaluation results, wear was noted to the coating on some portions of the guide wire.Therefore, it is possible that excessive force and/or advancement technique out of the guide wire contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the reported event.

• 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: 7485228
• Report Number: 2020394-2018-00548
• Device Sequence Number: 11170273
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/24/2019

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: HUCP1269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 58