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

Model Number	PICC-142
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the lhr for fg-picc-142 lot #09032001 was performed and did not reveal any anomalies or deviations or nonconformances.
Event or Problem Description
The complainant reported that when the hydropicc was removed, a "huge clot was in/on the catheter" and was completely occluded.

• 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
• MDR Report Key: 12433180
• Report Number: 3015060232-2021-00004
• Device Sequence Number: 4738962
• Product Code: LJS
• UDI-Device Identifier: 00862559000449
• UDI-Public: (01)00862559000449(17)210924(10)09032001
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: No Information
• Device Expiration Date: 09/24/2021
• Device Model Number: PICC-142
• Device Catalogue Number: PICC-142
• Device Lot Number: 09032001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1