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

Catalog Number 21-4170-24

Device Problems Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

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

Event Date 04/03/2023

Event Type  Injury  

Event Description

It was reported that a patient had porta cath insertion on (b)(6) 2015 and was scheduled for porta cath removal on (b)(6) 2023.Upon attempted removal, difficulty was encountered.The port was successfully removed at chest incision.Neck incision was made, and the catheter was found to be densely adherent and unable to be freed despite exploration down to retro clavicular area.Exploration of right upper chest wound.Port successfully removed, catheter removal with resistance plus exploration of neck wound: catheter was densely adherent, unable to free adhesion despite exploration down to retro clavicular area.Event occurred while in use with the patient, but no patient injury was reported.

Manufacturer Narrative

Other, other text: no product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Type of Device: 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: 17560180
• MDR Text Key: 321287315
• Report Number: 3012307300-2023-08171
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586012693
• UDI-Public: 10610586012693
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K994216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 21-4170-24
• Device Lot Number: 2535972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention