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

Model Number 21-4485-24

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 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
• Type of Device: PORT-CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12460846
• MDR Text Key: 271056639
• Report Number: 3012307300-2021-09328
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032790
• UDI-Public: 10610586032790
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1