MAUDE Adverse Event Report: ST PAUL DELTEC; PORT

Model Number 21-4475-24

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2018

Event Type  Injury  

Event Description

It was reported the guidewire was frayed and broke during an attempted port placement at the subclavian vein port, leaving a piece of the broken wire in the patient, causing surgeon's concern regarding removal of the guidewire and the patient's safety.A decision was made to transfer the patient to the main hospital (ems) where diagnostic imaging was available (ct) and the wire was safely removed.No additional adverse patient effects were reported.

Manufacturer Narrative

Summary of investigation: actual device was available for investigation.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The sample was received with the outer coil wire frayed and the fixed core wire end it is exposed.The most probable root cause is that the guidewire was received damaged from the supplier.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: DELTEC
• Type of Device: PORT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13115025
• MDR Text Key: 283472392
• Report Number: 3012307300-2021-13491
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 21-4475-24
• Device Lot Number: 3776603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1