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

Model Number	PICC-142 CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Observed a break/cut in a catheter.
Additional Manufacturer Narrative
The complainant reported that the picc was inserted on (b)(6) 2024 and removed on (b)(6) 2024 due to a cracked and leaking luer.The line was replaced without any impact on the patient.The incident was reported to avi on (b)(6) 2024, and on (b)(6) 2024, avi determined that the incident was not mdr reportable.The line was returned to avi and evaluated on 15aug2024.During the evaluation, avi identified a break in the catheter wall that was not initially reported by the user.On 05sep2024, avi determined that the break was mdr reportable.The break appeared as a straight, perpendicular cut or incision at the 5.1 cm mark.The shape of the cut, along with the absence of material deformation, suggests that it was likely caused by an external force rather than internal stress or pressure.The investigation indicates that the line was damaged by the securement device at some point during use; however, the exact mechanism causing the cut could not be determined.It was also identified that the securement device used was not the one included in the avi procedure kit.A review of the lot history revealed no nonconformances associated with the production lot.

• 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: 20184918
• Report Number: 3015060232-2024-00018
• Device Sequence Number: 8930935
• Product Code: LJS
• UDI-Device Identifier: 00862559000487
• UDI-Public: (01)00862559000487
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• 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): 09/10/2024

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: 03/28/2025
• Device Model Number: PICC-142 CM
• Device Catalogue Number: 80001104
• Device Lot Number: 11560170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (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