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

Catalog Number	21-4483-24
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a patient had a port a cath placed on (b)(6)2020.On (b)(6)2023 medical facility notes indicates the following: patient for cvc mediport flush in fast track.Port in r chest accessed without difficulty, no blood return after 1 cc flush, flushed with 4 cc of nss and area above port access became edematous and cool to touch?.Patient denied pain with flushing, but slight discomfort with palpitation of area.Charge rn and np notified for assessment.Stat chest x-ray was ordered, and the port de-accessed.Chest x-ray results: there is a right sided mediport.There is a separation of the catheter from the port measuring 1.1 cm.There is no distal migration of the catheter.The catheter tip overlies the svc.Patient was transferred to the ed where the port a cath was removed bedside by the surgeon.Adverse patient effects are unknown.
Additional Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were 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: 17494254
• Report Number: 3012307300-2023-07964
• Device Sequence Number: 12606766
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: 10610586032776
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 10/05/2024
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3894409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White