MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARRD PEG SAFETY SYSTEM - "GUIDEWIRE"; PEGS

Model Number	006036
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed and it appeared that the damage occurred during use.One guidewire from a peg kit was returned for investigation.The core wire broke near the distal weld tip.The break exhibited an uneven and granular surface.The core wire exhibited necking at the break site, which is consistent with a break due to tensile stress.The break allowed the distal end of the coil wire to stretch over the core wires.The coil wire stretched approximately 95 cm beyond the broken end of the core wire.The distal 48 cm of the coil wire remained tightly coiled.It was reported that the guidewire was damaged prior to use; however, the entire guidewire had been removed from the hoop.The hoop was not returned for investigation.It is possible that the guidewire was subject to tensile stresses while trying to remove the wire from the hoop.It is unknown if this was a factor, but the ifu indicates to remove the guidewire retaining plug from the hoop before pulling the guidewire from the retaining hoop.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the guidewire was damaged prior to use.No patient involvement.

• Brand Name: BARRD PEG SAFETY SYSTEM - "GUIDEWIRE"
• Common Device Name: PEGS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7007467
• Report Number: 3006260740-2017-01975
• Device Sequence Number: 444648
• Product Code: KNT
• UDI-Device Identifier: 00801741081194
• UDI-Public: (01)00801741081194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 006036
• Device Catalogue Number: 006036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1