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

Catalog Number	21-4083-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date.D6: implanted date and h4: manufacture date are unknown, no information has been provided to date.Device evaluation: one device was received for investigation.Visual inspection found the catheter was observed to be broken from the proximal side at the connection between the port and catheter.No other damage or dysfunctional conditions were observed.The reported failure mode, broke, was confirmed.Based on the analysis performed on the returned unit, and review of the mitigations during the manufacturing process, the root cause cannot be associated as manufacturing caused.No lot number was provided, therefor no device history report (dhr) review could be completed.No corrective actions taken at this time.This failure will continue to be monitored to determine if new actions need to be taken.
Event or Problem Description
It was reported that the oncology nurse station received a return visit from a patient.Upon inspection, the patient's infusion port and port body were not accessible.The "hong kong body" was broken, which was confirmed with film analysis.It was then removed from the port in the digital subtraction angiography (dsa) operating room.The break occurred at the junction between the port body and the catheter.The patient infusion port was installed 4 years ago, and the surgical location was on the upper arm.Since the hospital and the patient's own implant files are not kept, the specific batch number and specific sales date cannot be known.The incident resulted in no "patient casualties".The final result was that the "hong kong body" was removed and a new infusion port was implanted.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17482152
• Report Number: 3012307300-2023-07884
• Device Sequence Number: 8901903
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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 Catalogue Number: 21-4083-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown