MAUDE Adverse Event Report: MEDCOMP 14F X 24CM SPLIT CATH III; SPLIT CATH III HEMODIALYSIS CATHETER

Model Number	ASPC24-3E.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of placement procedure with seldinger technique echo-guided, while removing tear-away sheath, tear-away tabs broke preventing this operation.Klemmer forceps were used afterward to remove the sheaths.
Additional Manufacturer Narrative
All manufacturing processes were reviewed and nothing out of specification was found.Based on the investigation performed the failure mode may be related to the manufacturing process that involves the presence of the slit on the valve tearaway.Incorrect or missing scoring of the sheath could cause difficulty splitting the sheath resulting in the reported condition.Without an evaluation of the device involved this condition cannot be confirmed.

• Brand Name: 14F X 24CM SPLIT CATH III
• Common Device Name: SPLIT CATH III HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7994572
• Report Number: 2518902-2018-00054
• Device Sequence Number: 1301693
• Product Code: MSD
• UDI-Device Identifier: 00884908003512
• UDI-Public: 884908003512
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 12/28/2022
• Device Model Number: ASPC24-3E.
• Device Catalogue Number: ASPC24-3E.
• Device Lot Number: MLBC300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: 66 YR