MAUDE Adverse Event Report: NORFOLK MEDICAL PRODUCTS, INC. NORPORT SINGLE LUMEN PORT - COLOMBIA; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number NP-31412KV

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

A disconnection was reported to (b)(4) on or around (b)(6) 2019.It was later determined to be a catheter rupture.The port was placed in (b)(6) 2019, but reportedly did not work during the second chemotherapy session in (b)(6) 2019.The port was not removed until (b)(6) 2019.No other similar complaint has been reported to us on this lot of access ports released in november 2018.Investigation results were provided via email by our distributor.An x-ray picture taken just after implantation was provided.We can see that the catheter was placed in the costoclavicular space.Such placement can to lead to pinch-off' syndrome, ultimately causing the catheter to fracture/rupture.However, a corresponding x-ray image prior to explant was not provided for analysis.Several images of the explanted device were also provided via email.The images show an ovalized shape at the point of rupture approximately 6-6.5cm from the port stem which corresponds to where the catheter enters the subclavian vein per the provided x-ray.Additionally, the appearance of the fractured catheter is jagged and interrupted, consistent with friction and rubbing over a period of time.This information suggests the catheter was likely pinched and/or kinked at this location, further indicating pinch-off syndrome.The instructions for use warn against the risk entailed by placing via the subclavian route.This does not indicate a device related incident.Consequently, no corrective action is deemed necessary.Upon receiving new or additional information, a follow-up report will be submitted as applicable.

Event Description

A disconnection was reported, but upon receipt of further information, it was determined to be a fracture/rupture of the catheter.

• Brand Name: NORPORT SINGLE LUMEN PORT - COLOMBIA
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NORFOLK MEDICAL PRODUCTS, INC.; 7350 n. ridgeway avenue; skokie IL 60076
• Manufacturer (Section G): NORFOLK MEDICAL PRODUCTS, INC.; 7350 n. ridgeway avenue; skokie IL 60076
• Manufacturer Contact: natan pheil ; 7350 n. ridgeway avneu; skokie, IL 60076 ; 8476747075
• MDR Report Key: 9504700
• MDR Text Key: 219763559
• Report Number: 1450392-2019-00006
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Public: +M991NP31412KV1L+$$8011120NM1811DL7
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2019

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: 11/01/2020
• Device Catalogue Number: NP-31412KV
• Device Lot Number: NM1811D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR