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

Model Number	21-4455-24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165); Implant Pain (4561)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2023-00428
• Device Sequence Number: 12513913
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American