MAUDE Adverse Event Report: ACCESS VASCULAR. INC. HYDROPICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	PICC-142CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report of a fractured line.
Additional Manufacturer Narrative
The complainant reported that the catheter was leaking, and it was removed on (b)(6) 2024.No information was provided about any patient impact associated with the leaking catheter.The line was returned to avi on 13 january 2025.Two large/severe kinks were found at 7cm and 10cm.The kink at 7cm was ruptured.The 10cm kink did not rupture, but part of the wall was perforated.The two kinks formed a z-shape.A thrombotic occlusion was found from the tip (46cm) to a minor kink at 39cm.The full occlusion was 7cm long.Minor kinks were found near the tip at 40cm, 39cm, and 35.5cm.Under microscopic evaluation, the 7cm rupture shows evidence that the catheter walls stretched due to internal pressure causing the rupture.The review of the lot history record did not identify any nonconformances related to catheter production.The break in the line was confirmed, but a root cause could not be determined.

• Brand Name: HYDROPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER 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 ; 9785966862
• MDR Report Key: 21211779
• Report Number: 3015060232-2025-00001
• Device Sequence Number: 18160177
• Product Code: LJS
• UDI-Device Identifier: 00850030354303
• UDI-Public: (01)00850030354303
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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 Expiration Date: 01/13/2026
• Device Model Number: PICC-142CM
• Device Catalogue Number: 80H01104
• Device Lot Number: 03152401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown