MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20F GUIDEWIRE DELUXE PEG; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: no manufacturing issues associated to the reported event were found in the reviewed lot.Device history records (dhr) review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records.Product passed all required inspections at each step at end product level.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.Investigation summary: the complaint of a damaged guidewire was confirmed, and the cause appeared to be associated with use of the device.Two segments of the peg guidewire, the grasping snare, and the dilating tip of the peg tube were returned for investigation.The dilating tube had been cut from the peg tube and the peg tube was not returned for investigation.No damage was observed on the grasping snare.One segment of the wire was 13.5cm in length.The core wire was exposed.The other guidewire segment was curled and kinked 1.2cm from the weld tip.The wire was incomplete.A microscopic examination of the exposed core wires revealed that the wire appeared severed.A tactual investigation revealed that the coil wires could be stretched over the exposed end of the core wires.A functional test of the guidewire could not be completed with the condition of the returned sample.A functional test of the snare revealed nothing remarkable.An unused guidewire was passed through the dilating tip of the peg tube without resistance.The outside diameter of the guidewire was within specification.The damage observed on the guidewire can be caused from retraction or movement against resistance and sharp instrument damage.No damage associated with the manufacturing process was observed on the returned samples.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.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 by the facility that the insertion wire would not feed through the peg tube.A second device was opened and the physician was unable to open the snare.Procedure was completed with another device.This file addresses the allegedly defective insertion wire.No injury to the patient.

• Brand Name: 20F GUIDEWIRE DELUXE PEG
• 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: 7943784
• Report Number: 3006260740-2018-02814
• Device Sequence Number: 941050
• Product Code: KNT
• UDI-Device Identifier: 00801741000478
• UDI-Public: (01)00801741000478
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: HUAT0717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1