MAUDE Adverse Event Report: ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number	21-4453-24
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
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 required.
Event or Problem Description
It was reported that during removal, the catheter broke off from the chamber and moved towards the heart.That same day, the patient was transferred to a clinic for a minimally invasive catheter intervention (miki) to remove the foreign body.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Two pictures attached to the complaint where it was observed the port with a section attached to the port and a remained catheter section.Visual inspection observed that a section of catheter was attached in the port-catheter connection section under the sleeve, thus, the complaint was confirmed.A destructive test was performed on one (1) sample that was taken from the manufacturing process.Then a catheter piece for the corresponding model was inserted and manipulated in order to pull the catheter to attempting reproduce the failure mode.It was necessary keep the sleeve on the bottom of the tube to remove the catheter without damage; when the catheter was just pulled allowing that the sleeve ascend, a catheter piece was trapped in the sleeve.Instructions for use address this warning.Root cause cannot be associated with manufacturing process since the failure could not be reproduced following the assembly process.The most probable root cause is that damage occurred after the product left the manufacturing facilities.Root cause could not be established.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.No corrective actions are required since the root cause could not be attributed to the manufacturing process.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• 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: 16898662
• Report Number: 3012307300-2023-05420
• Device Sequence Number: 15163038
• Product Code: LJT
• UDI-Device Identifier: 10610586032684
• UDI-Public: 10610586032684
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/25/2023

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: Health Professional
• Device Model Number: 21-4453-24
• Device Catalogue Number: 21-4453-24
• Device Lot Number: 4276230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White