MAUDE Adverse Event Report: BARD / C. R. BARD, INC. POWERPICC SOLO 2 HF CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	1395108QD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Initial guidewire was being fed through the introducer needle into a vessel in the patient's left upper arm.There was difficulty threading the needle through the arm.When attempting to back wire out of arm there was resistance felt at the insertion site of the introducer needle.When introducer needle and wire were pulled from the patient's arm, there appeared to be part of the wire remaining in patient's left upper arm.The thin remnant of wire was pulled from the patient's arm.Dr noted the fragment was small enough that it would be difficult to find to surgically remove.So they did not do any interventions to remove.Pt was discharged to guards with no documented issues in the arm.Fda safety report id# (b)(4).

• Brand Name: POWERPICC SOLO 2 HF CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD / C. R. BARD, INC.; covington GA 30014
• MDR Report Key: 15156154
• Report Number: MW5111243
• Device Sequence Number: 14890113
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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: 03/31/2023
• Device Model Number: 1395108QD
• Device Catalogue Number: 1395108QD
• Device Lot Number: REFY3718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White