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

Model Number	MC101242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is import for export only, not sold in the us.Udi not applicable.We are 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
While removing the indwelling catheter from the tunnel after having dissected the tissue surrounding the cuff the catheter tore in half at the cuff point completely.The distal half was completely removed ant the proximal half was free floating on the guide wire placed through the catheter svc to ra to ivc at the beginning of the procedure.A cutdown was performed over a more proximal part of the catheter at the cuff and it was safely removed without embolizing to the pulmonary arteries.A new permcath was then introduced over the wire after having maneuvered the wire back through the original tunnel.
Additional Manufacturer Narrative
One 12.5f x 18cm long-term hemo-cath was returned for evaluation in two pieces.The first piece is the hub, extension and a 5.3cm length of lumen.The second piece is a 13.3 section of tubing that includes the cuff.The lumen broke at the proximal edge of the cuff.The edge of the break is jagged.Under magnification a small piece of glue can be seen on the lumen just past the point of breakage.The device was further evaluated by medcomp engineering and it is determined the glue is from the procedure that attaches the cuff to the lumen and would have played no role in the lumen breakage.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted for close to three months with no reported issues.The reported break of the lumen occurred during removal of the device when surgical removal of a fibrin sheath is required.A root cause cannot be determined but is not likely manufacture related.The likely cause for the lumen breaking is that the lumen was damaged while the cuff was being dissected from the surrounding tissue and tore during the removal process.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.

• Brand Name: SLX 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: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 20577791
• Report Number: 2518902-2024-00075
• Device Sequence Number: 15454493
• Product Code: MSD
• UDI-Device Identifier: 00884908082999
• UDI-Public: 00884908082999
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: Other
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 25 KG