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

Catalog Number 21-4483-24

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported by the customer that the catheter has broken and migrated.The reservoir implantation date was (b)(6) 2019, in the subclave, in the left side.The patient reported pain around the reservoir 10 or 15 days ago and they decided to remove it due to possible infection.At that moment of the event, they detected that the catheter is not complete and that a piece is missing.The event occurred during in use with a patient; however, there was no harm or injury.The patient required interventional radiology to remove the piece of catheter.

Manufacturer Narrative

Other text: 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.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.One (1) unit sample was received in decontaminated condition without its original packaging.Two pictures were included where it is observed the port with a section attached to the port.No catheter has returned; however, it is observed that a section of catheter is attached in the port-catheter connection section under the sleeve, additionally brown spots are observed between the remained catheter section and the port and several punctures on the septum and septum?s housing are observed.The complaint was confirmed.A root cause for the condition was unknown and the most probable cause is that damage occurred after the product left the manufacturing facilities since the failure could not be reproduced following assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions since the root cause could not be attributed to the manufacturing process.

Event Description

Additional information received by email, the patient received treatment with paclitaxel, adraimycin and cyclophosphamide and currently carries another port-a-cath.

• Brand Name: DELTEC TITANIUM IMPLANTABLE PORT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17898979
• MDR Text Key: 325244554
• Report Number: 3012307300-2023-09155
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: 10610586032776
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3603214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2018
• 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: 39 YR
• Patient Sex: Female
• Patient Race: White