MAUDE Adverse Event Report: ST PAUL DELTEC TITANIUM PORT-A-CATH; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number 21-4455-24

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165); Implant Pain (4561)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

The patient reported pain at the site after undergoing chemotherapy.A pac study was done which identified a fracture in the device below the clavicle.During the device removal, the pac reservoir was removed and preserved for return to the manufacturer.A fracture was noted at the hub of the reservoir where the catheter was anchored to the device.The remaining catheter had retracted into the vein, inferior to the clavicle and the surgeon was not able to retrieve the catheter.The patient was referred to interventional radiology for removal.Additional information received by smiths medical/icu on 04-jan-2022 via email: patient underwent catheter retrieval and port replacement (today) (b)(6) 2022 at a tertiary care center.Patient had a chest x-ray done and fluoroscopy for the catheter retrieval and port insertion and had to go to a tertiary care center for catheter removal in interventional radiology and to have a second port placed.

Manufacturer Narrative

Health impact and evaluation codes: updated.No product was returned therefore no investigation could be performed.A device history record (dhr) review showed there were no reported discrepancies during the manufacturing of the reported lot number.If the device is returned the manufacturer will re-open the investigation.

• Brand Name: DELTEC TITANIUM PORT-A-CATH
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16152042
• MDR Text Key: 307257176
• Report Number: 3012307300-2023-00428
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4455-24
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 4248703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American