MAUDE Adverse Event Report: ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number	21-4455-24
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was sent to have the device removed due to it breaking.The device was implanted (b)(6) 2023 and recently developed an "issue".Adverse patient effects are unknown.
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: h6: evaluation codes updated.Device evaluation: two samples were received for investigation.After examining under magnification, it appears that the catheters failed in tension on one side of the catheter at the end of the outlet due to bending.On one of the two, the tear propagated across the catheter causing complete separation.A dhr review was unable to be completed as the lot number was not provided.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17616190
• Report Number: 3012307300-2023-08390
• Device Sequence Number: 2608822
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4455-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown