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

Catalog Number	21-4170-24
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 17560180
• Report Number: 3012307300-2023-08171
• Device Sequence Number: 5045290
• Product Code: LJT
• UDI-Device Identifier: 10610586012693
• UDI-Public: 10610586012693
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown