MAUDE Adverse Event Report: MEDCOMP 10F X 15CM HEMO-CATH; HEMODIALYSIS CATHETER

Model Number	MC101041P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
During removal of perm-cath the catheter cut and migrated to the heart.Implanted for 1 year.
Additional Manufacturer Narrative
Based on the investigation completed, this was not due to a manufacturing issue.The catheter lumen appears to have perpendicular cuts along the shaft and at no point during the manufacturing operations is a perpendicular cutter used on the lumen.The device history record was reviewed and no there were no discrepancies noted in the manufacturing processes of this lot.The catheter passed all tensile strength requirements during testing the finished catheter also under goes a 100% visual inspection for cuts as well as a 100% leak test.

• Brand Name: 10F X 15CM HEMO-CATH
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6698347
• Report Number: 2518902-2017-00035
• Device Sequence Number: 16393666
• Product Code: MSD
• UDI-Device Identifier: 00884908093261
• UDI-Public: 884908093261
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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 Expiration Date: 01/31/2020
• Device Model Number: MC101041P
• Device Catalogue Number: MC101041P
• Device Lot Number: MBXR610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 06/08/2018
• 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 Age: 6 YR
• Patient Weight: 20