MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA 4 FR CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number S1274108D

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Difficulty advancing guidewire noted during picc insertion.Guidewire removed and kinks noted.Picc line placed and x-ray used for confirmation d/t tip confirmation system not working correctly.Initial x-ray confirmed picc placed in correct position, along with a small object that could be broken piece of guidewire.Radiologist confirmed a 1.9 cm thin linear radiodensity overlying the right axilla.Patient sent to ir for retrieval, which was unsuccessful d/t broken fragment migrating to tricuspid valve.Decision made to not attempt retrieval due to risk.Patient asymptomatic at this time.Fda safety report id# (b)(4).

• Brand Name: POWERPICC PROVENA 4 FR CATHETER WITH SHERLOCK 3CG TIP
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 14337307
• MDR Text Key: 291325911
• Report Number: MW5109595
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: S1274108D
• Device Catalogue Number: S1274108D
• Device Lot Number: REFS1619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG