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	08/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "acute deep venous thrombosis (dvt) is noted involving the right axillary vein(s).Acute deep venous thrombosis (dvt) is noted involving the right axillary vein(s).Thrombus was associated with a picc line.Acute superficial venous thrombosis (svt) is seen involving the right basilic vein of the upper arm.Thrombus was associated with a picc line." it was also reported that on (b)(6) 2021: "no change in patient condition.".
Event or Problem Description
It was reported that: "acute deep venous thrombosis (dvt) is noted involving the right axillary vein(s).Acute deep venous thrombosis (dvt) is noted involving the right axillary vein(s).Thrombus was associated with a picc line.Acute superficial venous thrombosis (svt) is seen involving the right basilic vein of the upper arm.Thrombus was associated with a picc line." it was also reported that on (b)(6) 2021: "no change in patient condition.".

• 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
• Manufacturer (Section G): ACCESS VASCULAR INC.; 175 middlesex turnpike; bedford MA 01730
• Manufacturer Contact: ken hirakawa ; 175 middlesex turnpike; bedford, MA 01730 ; 7815386594
• MDR Report Key: 12934252
• Report Number: 3015060232-2021-00006
• Device Sequence Number: 4957673
• 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