MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 10C; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redy0622 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a radstick guidewire became unraveled and broke while being inserted into the patient.The piece was removed from the patient on site without further surgery.Additional information received 8/3/2020: it was reported the left basilic vein was accessed using us guidance.Radstick guidewire inserted and met resistance.During removal of guidewire, had uncoiling of wire and breakage into two (2) pieces and end of guidewire lodged in patient.Radiologist removed lodged guidewire under fluoroscopy.No patient harm reported.

• Brand Name: RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 5F X 10C
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10404863
• Report Number: 3006260740-2020-02924
• Device Sequence Number: 11511118
• Product Code: DYB
• UDI-Device Identifier: 00801741074585
• UDI-Public: (01)00801741074585
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 0669050
• Device Lot Number: REDY0622
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR