MAUDE Adverse Event Report: ST PAUL DELTEC; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	21-4453-24
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Codes	Extravasation (1842); Patient Problem/Medical Problem (2688)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.(b)(6).
Event or Problem Description
It was reported that the deltec power port-a-cath ii was set on the 22-july.There was no indication of a contrast medium extravasation in the c-arm.This was not observed on 22-july.On 23-july chemotherapy (epirubicin) was started.The patient complained of a pronounced pain in the port area.A clear extravasation was found during a functional test with a mobile x-ray.The port was removed on the same day as a result of this.No further patient complications were noted.There was no discoloration of the catheter, however a leak was verified on the catheter just two cm distal to the aforementioned site.The operator noted a slit-shaped lesion in the catheter.The defective product was returned to the manufacturer for further device investigation.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: DELTEC
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10488246
• Report Number: 3012307300-2020-06907
• Device Sequence Number: 2476326
• Product Code: LJT
• UDI-Device Identifier: 10610586032684
• UDI-Public: 10610586032684
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: 21-4453-24
• Device Catalogue Number: 21-4453-24
• Device Lot Number: 3968109
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 12/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1