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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported a picc line that needed to be removed due to swelling and redness.Upon pulling the line and examining it, a defect was observed.
Additional Manufacturer Narrative
On (b)(6) 2022, (b)(6) (b)(4) called (b)(6) (b)(4) that he had a picc line that would need to be removed due to swelling/redness.Upon pulling the line the next day and examining the catheter, he noticed what looked like a puncture.The line was placed on (b)(6) 2022 and had been used to infuse vancomycin.No other patient information was provided.The catheter was returned for further investigation, and avi received the sample on (b)(6) 2023.The following was noted: - on the underside of the catheter, which would be in contact with the patient's skin, a leak location was observed 0.5cm from the suture wing.See attachment #1.- on the topside of the catheter, which would be away from the patient's skin, a defect was observed 0.5cm from the suture wing (opposite the leak noted above).It is possible that a leak occurred in this location, but was later sealed with biological material.See attachment #2.The catheter was then dissected.An occlusion was found starting 1.7cm from the suture wing and continuing from the proximal end for 17.0cm (terminating at 18.7cm from the suture wing).See attachment #3.No occlusions were found from the luer to 1.7cm from the suture wing, or from 18.7cm to the distal tip.Avi works with argon medical devices to kit, sterilize, and ship our products to customers.Part of argon's kitting process is to take avi catheter lots and combine them into their own for continued processing.Records show there were three avi catheter lots used to create argon lot #11423949: 10212102, 11092101, and 11232101.For this investigation, all three internal catheter lot lhrs were reviewed and there were no deviations that would have contributed to the reported issue.Investigation of the returned device confirmed that at least one leak was present, and that the most likely cause of failure is the 17cm long occlusion in the catheter lumen.Per the hydropicc instructions for use (ls-049), which is printed and provided within each kit, the catheter should be flushed after every use.When not in use, the catheter should be flushed at least every 12 hours to ensure patency.Due to the occurrence, size, and location (in the body of the catheter vs.The distal tip) of the occlusion, it can be assumed that flushing was not conducted by the customer per the ifu.

• 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: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 16234060
• Report Number: 3015060232-2023-00003
• Device Sequence Number: 6405291
• Product Code: LJS
• UDI-Device Identifier: 00862559000487
• UDI-Public: (01)00862559000487
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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: 02/11/2024
• Device Model Number: PICC-142
• Device Catalogue Number: 80001004
• Device Lot Number: 11423949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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