MAUDE Adverse Event Report: ST PAUL DELTEC POWER PORT-A-CATH II VENOUS ACCESS; PORT-CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS

Model Number	21-4485-24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The device was examined; this showed the catheter was still attached to the portal; however a crack was found along the length of the catheter.The device was given functional testing and no leakage was found.While a crack was found in the material no functional issues were identified.The manufacturing process includes a patency test for the catheter to verify no damage prior to packaging.The reported issue could not be attributed to a manufacturing issue; the likely cause was determined to have occurred due to stress during use.
Event or Problem Description
It was reported the device was in patient use.The device was removed due to a hole found in catheter that was identified upon fluoroscopy.The surgical removal occurred with no further adverse effects reported.

• Brand Name: DELTEC POWER PORT-A-CATH II VENOUS ACCESS
• Common Device Name: PORT-CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12460846
• Report Number: 3012307300-2021-09328
• Device Sequence Number: 11975141
• Product Code: LJT
• UDI-Device Identifier: 10610586032790
• UDI-Public: 10610586032790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 21-4485-24
• Device Catalogue Number: 21-4485-24
• Device Lot Number: 3795696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1