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	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a port-a-cath that was in use for two years was found separated from or broken apart from the port inside the patient.An x-ray was taken to see the product "free floating" in the body.Device was surgically removed.No adverse effects reported.
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.Three (3) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received in the manufacturing site.Results: photo one shows a screen where an x-ray image is shown, the x-ray image appears to be of a chest where the mouse pointer points to the left side of the image; from this photo the port, catheter, or reported failure are not visible.Photo two shows the port removed with the catheter attached.Next to the catheter a hemostatic forceps are observed; the catheter is observed to be broken from where it connects to the port.Photo three shows the port next to the hemostatic forceps; in this photo the catheter is observed to have been completely removed leaving a small part of the catheter attached to the port connector.The reported failure mode, broken, is confirmed.Root cause could not be established.No lot number was provided, therefore no device history report (dhr) review could be completed.If the product is returned, the manufacturer will reopen this complaint for further 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16899383
• Report Number: 3012307300-2023-05433
• Device Sequence Number: 12467243
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 21-4455-24
• Device Catalogue Number: 21-4455-24
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown