MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	PICC-142
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up telephone conversation with mr.Bunch realized that the catheter had not kinked or cracked (as originally reported), and that the defect was clearly a hole in the catheter.The hydropic was explanted and replaced with a midline catheter since a picc was no longer needed for treatment.
Event or Problem Description
It was reported that the hydropic catheter had been successfully implanted on (b)(6) 2020 without any issues.Then, nine days later, it was reported that the catheter had retracted approximately 6 cm outside the patient and that a crack in the catheter became evident after attempting to flush it.

• Brand Name: HYDROPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford MA 01730 1940
• MDR Report Key: 10514468
• Report Number: 3015060232-2020-00004
• Device Sequence Number: 2605002
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)201020(10)07312002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 10/20/2020
• Device Model Number: PICC-142
• Device Catalogue Number: PICC-142
• Device Lot Number: 07312002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other