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

Model Number	ASPC24-3E.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved was discarded by the facility and not returned for evaluation.Photographs were provided.The photograph revealed a slice in the lumen.The slice was reported to have been under the gauze dressing.The ballooning occurred after the lumen was clamped to prevent blood loss through the slice.As the device was implanted for approximately one year, the root cause of ballooning is most likely not due to a manufacture issue.Without an evaluation of the actual device, a definitive root cause cannot be determined.
Event or Problem Description
After being implanted for approximately 12 months, the lumen of the catheter was noted to balloon.A slice/cut appears on a portion of the lumen which was under a gauze dressing.The ballooning was reported to occur after the catheter was clamped to block the blood from leaking out from the slice.The catheter was used only for dialysis and was not used for power injections.Catheter was removed.

• Brand Name: 14F X 24CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8921139
• Report Number: 2518902-2019-00056
• Device Sequence Number: 11269700
• Product Code: MSD
• UDI-Device Identifier: 00884908003512
• UDI-Public: 884908003512
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: ASPC24-3E.
• Device Catalogue Number: ASPC24-3E.
• Device Lot Number: MLCP800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 45