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

Model Number	PICC-142S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the lot history record for lot #03042101, including lot release test data, was performed, which did not reveal any anomalies that could be attributed to the reported issue.
Event or Problem Description
It was reported that during the patient's third visit: "patient had the following: left brachial veins-acute thrombus, picc line: partial compression:normal phasic flow.Left ulnar veins: acute thrombus, picc line: no compression left basilic veins: upper arm, acute thrombus, picc line, no compression left cephalic vein: upper arm, acute thrombus: no compression left cephalic vein: forearm: acute thrombus: no compression [the physician] was notified the same day as event.[the physician] verified results.Patient was placed on anticoagulation by attending.Patient is asymptomatic.".

• Brand Name: HYDROPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford MA 01730 1459
• Manufacturer (Section G): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford MA 01730 1459
• Manufacturer Contact: kenneth hirakawa ; 175 middlesex turnpike; suite 1a; bedford, MA 01730-1459
• MDR Report Key: 12933663
• Report Number: 3015060232-2021-00005
• Device Sequence Number: 4906993
• Product Code: LJS
• UDI-Device Identifier: 00862559000425
• UDI-Public: (01)00862559000425(17)211216(10)03042101
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 12/16/2021
• Device Model Number: PICC-142S
• Device Catalogue Number: PICC-142S
• Device Lot Number: 03042101
• 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: 11/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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