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

Model Number 21-4453-24

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problems Extravasation (1842); Patient Problem/Medical Problem (2688)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.(b)(6).

Event 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.

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
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10488246
• MDR Text Key: 205498147
• Report Number: 3012307300-2020-06907
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032684
• UDI-Public: 10610586032684
• Combination Product (y/n): N
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1