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

Model Number	HYDROMID
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a patient with a hydromid that developed thrombus.
Additional Manufacturer Narrative
On 04oct2023, (b)(6) provided an excel sheet with information about avi catheters that needed to be removed due to various malfunctions.One of these was a report of thrombus at a dwell time of one day.On 23oct2023, (b)(6) provided additional details: · the line was placed on (b)(6) 2023.The order stated that more access was needed.The patient received two doses of valproate.· doppler showed thrombus in the same vein as the hydromid from the proximal forearm to the distal clavicle and the line was removed on (b)(6) 2023.· lee noted that he's confident that the ifu was followed for proper care and maintenance during insertion, but he can't be sure about the level of maintenance after that unless he performs an audit.· no photos were taken, and the device was discarded by the user and therefore unavailable for return to avi for further investigation.The lot number provided (#11477925) is assigned by argon medical (avi's approved supplier for kitting).This kit contained catheters from two different avi catheter lot numbers: #03132301 and #04112303.For this investigation, both lhrs were reviewed.No nonconformances or deviations that could have contributed to the complaint issue were found.With the limited information provided and no return of the device, avi is unable to determine root cause.It is not known whether the hydromid device contributed to the reported thrombus.

• 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: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 18041238
• Report Number: 3015060232-2023-00011
• Device Sequence Number: 7468662
• Product Code: FOZ
• UDI-Device Identifier: 00850030354211
• UDI-Public: (01)00850030354211
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2024
• Device Model Number: HYDROMID
• Device Catalogue Number: 80004104
• Device Lot Number: 11477925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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