MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10FX18CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101042P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Upon the patient having an echo, it was noticed that the tip of the catheter line had broken off and had become lodged in his right pulmonary artery.Cardiac surgeons have recommended we leave it in situ as operating to remove it is more dangerous than leaving it in.
Additional Manufacturer Narrative
The 10f hemo-cath was returned for evaluation with 5.5 cm of the lumen attached to the hub.Although customer photographs show two pieces of the lumen, the returned device package contained only the main portion of the catheter.The internal portion of the device, where to tip broke, off was not returned.Visual inspection revealed no obvious defects on the portion of the lumen that was returned.The contract manufacturer conducted a review of the manufacture records for the lot number provided.This review determined that the catheter lot was manufactured according to specifications with no nonconformities or other abnormalities.There were no deviations or process changes in the manufacture and/or materials of the part number.All inspections and sequence of operations were properly followed and documented.The device was implanted and functioned with no issue for 20 months prior to this event.The issue with the catheter tip was discovered during a patient echo.It is unknown when the actual failure occurred.Without an evaluation of both pieces of the lumen a root cause cannot be determined.

• Brand Name: 10FX18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16644360
• Report Number: 2518902-2023-00026
• Device Sequence Number: 17681291
• Product Code: MSD
• UDI-Device Identifier: 00884908093278
• UDI-Public: 00884908093278
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/19/2023
• Device Model Number: MC101042P
• Device Catalogue Number: MC101042P
• Device Lot Number: MMAS090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 21 KG