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

Model Number	PICC-251
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported that the peripherally inserted central catheter (picc) line had been in place for approximately one week.On april 27, 2024, the patient facility reported a leak in the picc line.The patient also reported experiencing discomfort in their arm over the past few days.Upon examination, the complainant identified that the catheter was torn at the base near the suture wing tip.Although the complainant retained the catheter, it has not yet been returned for investigation.The manufacturer will follow up on this initial report once the investigation is complete.
Event or Problem Description
Report of a leak/break in a dual lumen catheter.
Additional Manufacturer Narrative
Avi submitted an initial mdr (3015060232-2024-00012) prior to the 30-day reporting requirement.The subject catheter was subsequently received by avi for investigation.Upon investigation it was observed that the catheter was severed at approximately 2.5cm from the suture wing tip.The break in the catheter showed no signs of kinks or other material fatigue.The cut appeared to be caused by a sharp object.The cause of the cut could not be determined.
Event or Problem Description
Report of a leak/break in a dual lumen catheter.

• Brand Name: HYDROPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER 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: elizabeth haines ; 749 middlesex turnpike; billerica, MA 01821 ; 9785966862
• MDR Report Key: 19392189
• Report Number: 3015060232-2024-00012
• Device Sequence Number: 7744033
• Product Code: LJS
• UDI-Device Identifier: 00850030354068
• UDI-Public: (01)00850030354068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: PICC-251
• Device Catalogue Number: 80002004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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