MAUDE Adverse Event Report: ST PAUL DELTEC; PORT

Model Number	21-4475-24
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2021-13491
• Device Sequence Number: 4653810
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown