MAUDE Adverse Event Report: ST PAUL DELTEC; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS

Model Number	21-4083-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the port-a-cath ii port was implanted on (b)(6) 2019 without any complications.The device was being used to administer chemotherapy for ovarian cancer.The device functioned as intended until (b)(6) 2020.A chest x-ray was then taken on (b)(6) 2020.According to the operator, the x-ray revealed that there was now an unspecified quality issue with device.The device was explanted as a result.No further complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the device was not received, evaluation was performed using a photo supplied by the customer.The photo showed a portal covered with what appears to be blood.The ultra lock section of the portal appears to have a section of the catheter within the lock ring component.No photo of catheter was provided for examination which would have been beneficial to the analysis.A definitive root cause was not able to be determined from the provided photo.

• Brand Name: DELTEC
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10810096
• Report Number: 3012307300-2020-11261
• Device Sequence Number: 14334159
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: No Information
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 3303094
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 05/19/2021
• 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: Hospitalization; Required Intervention