MAUDE Adverse Event Report: MEDCOMP MEDCOMP; TITAN HD CATHETER 15.5F X 24CM, CUFF 19CM

Model Number THD155024

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2020

Event Type  Injury  

Event Description

During a permacath placement, the guidewire coating broke off and sheared while removing the guidewire.Attempts to retrieve unsuccessful.

• Brand Name: MEDCOMP
• Type of Device: TITAN HD CATHETER 15.5F X 24CM, CUFF 19CM
• Manufacturer (Section D): MEDCOMP ; 1499 delp dr; harlyesville PA 19438
• MDR Report Key: 11055604
• MDR Text Key: 241252585
• Report Number: 11055604
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/20/2022
• Device Model Number: THD155024
• Device Lot Number: MPHH780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2020
• Distributor Facility Aware Date: 12/09/2020
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 115