MAUDE Adverse Event Report: ST PAUL DELTEC TITANIUM POWER PAC IMPLANTABLE PORT; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number	21-4483-24
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
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 additional reportable information becomes available.
Event or Problem Description
It was reported that the patient had an implantable port placed on (b)(6) 2019.On (b)(6) 2023, at the cancer center, the port was accessed with no blood return.Tpa injected due to possible clot by intake nurse.After 1 hour blood return not obtained.On (b)(6) 2023, "ivr-ir contrast injection check cv access performed".Customer stated "there was at least partial discontinuity of the catheter tubing at the connecting with the port pocket, with spillage of contrast into the subcutaneous tissues of the left neck.Contrast did opacity the entire length of the catheter." on (b)(6) 2023, due to the malfunction and discontinuity of the port, the port was removed in a surgical oncology outpatient office.The patient was a 65-year-old female with metastic melanoma found to have a nonfunctional port.Study was found to have the catheter disconnected from the tip of the port.Patient status post treatment: patient supine, the left chest skin was prepped and draped in sterile fashion.The skin was anesthetized with 1% lidocaine with epinephrine.An incision through the prior insertion site was made with a scalpel blade.The mediport was sharply dissected and removed grossly intact.The counter incision over the left clavicle and a counter incision over the internal jugular vein insertion site had to be made.In the end, vascular surgery had to be brought over to help remove the catheter safety from the insertion site at the ij.The device was sent for pathologic exam.The patient tolerated the procedure well.Patient will return in 10 days time for suture removal.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC TITANIUM POWER PAC IMPLANTABLE PORT
• 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: 17769451
• Report Number: 3012307300-2023-08995
• Device Sequence Number: 6273238
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: 10610586032776
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 02/28/2024
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3826325
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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: 65 YR
• Patient Sex: Female
• Patient Race: White