MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH P.A.S. PORT ELITE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number	21-4590-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Radiation Leak (1357); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/03/2023
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 the nurse found that the patient's neck was significantly swollen during the infusion of chemotherapy drugs, and the chemotherapy drugs leaked out.The connection of the port catheter was ruptured which shown by contrast agent during the digital subtraction angiography (dsa) at the radiology department.The device was then immediately removed.
Additional Manufacturer Narrative
Other, other text: d4: udi updated - (b)(4).H6: evaluation codes updated device evaluation: one device was received.During the visual inspection, no scuffs, pinch marks, cracks, crazing, cuts or other damages that could contribute to the failure mode reported are observed.During the functional testing, water was infused through the catheter with the intention to detect any leak.The water passed through the whole product until the catheter extreme as intended and drops leaked were detected; thus, failure mode is confirmed.After a review of the different verifications that are performed during the manufacturing process to detect damage components, root cause cannot be associated with manufacturing process since the failure could not be reproduced following assembly process.The most probable root cause is that damage occurred after the product left the icu medical facilities.No corrective actions are required since the root cause could not be attributed to the manufacturing process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: DELTEC PORT-A-CATH P.A.S. PORT ELITE
• 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: 16791926
• Report Number: 3012307300-2023-04410
• Device Sequence Number: 5523116
• Product Code: LJT
• UDI-Device Identifier: 10610586021541
• UDI-Public: 10610586021541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Model Number: 21-4590-24
• Device Catalogue Number: 21-4590-24
• Device Lot Number: 4227823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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