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

Model Number	PICC-142 CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported that the picc was inserted on (b)(6) 2024 and was removed on 2(b)(6) 2024 due to infiltration, swelling, and some pain.The line was removed, and the break in the catheter was identified approximately at the feet of a securement device.The line was returned to avi for investigation along with the securement device.The break had the appearance of a cut or incision at the 2cm mark, which aligned with the anchor tines of the securement device.The investigation suggests that the line was damaged by the securement device at some point during use.During the investigation, it was identified that the securement device utilized was not the device that is included in the avi procedure kit.
Event or Problem Description
Report of a break in a picc line.

• Brand Name: HYPOPICC
• 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
• MDR Report Key: 19352829
• Report Number: 3015060232-2024-00011
• Device Sequence Number: 7281346
• Product Code: LJS
• UDI-Device Identifier: 00850030354303
• UDI-Public: (01)00850030354303
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• 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
• Report Date (Section B): 05/20/2024

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: 12/07/2025
• Device Model Number: PICC-142 CM
• Device Catalogue Number: 80H01104
• Device Lot Number: 01152405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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