MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	MID-141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.Picture of device after removal proved inconclusive.No definitive root cause could be determined from the lot tracing and internal investigation.There were zero non-conformances identified during manufacturing.
Event or Problem Description
Patient arm swollen, catheter unable to be flushed.Catheter removed and replaced.Removed catheter observed to have a leak and a blood clot was present in the catheter leak and clot locations not stated.Patient stable after catheter replacement.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer (Section G): ACCESS VASCULAR, INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: scott blood ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 24405798
• Report Number: 3021570645-2026-00001
• Device Sequence Number: 18210206
• Product Code: FOZ
• UDI-Device Identifier: 00850030354358
• UDI-Public: 00850030354358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MID-141
• Device Catalogue Number: 80H04104
• Device Lot Number: 12192404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown