MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC POWERPORT ISP M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1808560

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

Patient scheduled for removal port-a-cath.Catheter broke during removal.Unable to retrieve remaining catheter.Doctor consulted and transferred patient for further treatment.Catheter successfully removed by interventional radiology.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 12575999
• MDR Text Key: 274794938
• Report Number: 12575999
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REYK0814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other