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

Model Number PICC-142

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2022

Event Type  Injury  

Event Description

Catheter leak/imperfection identified post removal.

Manufacturer Narrative

On friday, (b)(6) 2022, (b)(6) (rn/owner of (b)(6) care company) reported to (b)(4) (avi area sales manager) what he described as "faulty lines." he stated that he had two picc lines that had leaked - one on (b)(6) 2022 and one on (b)(6) 2022.When the second occurred, he became curious and when it was removed from the patient, he instructed his nurse to seal the end and flush it.This revealed an "imperfection about 6cm down the line allowing it to leak." (b)(6) provided an image as well as a video to avi to show the solution escaping from the wall of the catheter.Both lines were used to administer vancomycin and because of these leaks, the patients were not getting their full dose.No power injection was performed and nothing abnormal was noted during placement.No other patient info was provided.Avi issued rga #(b)(4) and (b)(6) returned the catheter and six unopened full kits from the same lot for further investigation.This mdr documents the first instance described above, which was not returned to avi for evaluation.The second instance has been submitted as (b)(4).Refer to this mdr for photos associated with the second instance.Although there were no images provided of the catheter from this incident and it was not returned to avi for investigation, an investigation was performed on the second catheter that (b)(6) had reported.Based on communication with the customer, avi is confident the defect is similar if not the same between the two incidents.During the investigation of the second instance ((b)(4)), two leaks were found along the catheter tube body (on the same catheter) and both were located along the taper and on the same side of the catheter.Specifically, both would be facing "up" if placed on the table with the suture wing flat.Leak #1 was 5.4cm from the tip of the suture wing and covered approximately 30% of the circumference of the catheter.Leak #2 was 4.6cm from the tip of the suture wing and was much smaller.Neither area has characteristics typically seen when a catheter bursts (deformed and/or stretched catheter walls originating from inside the catheter); rather, they appear to be straight cuts originating from the outside of the catheter.Leak #2 appears to have a shallow cut that narrowly breaches the catheter lumen, while leak #1 has a significant perpendicular cut to the radial axis.The unopened kits from the same lot that were returned were also evaluated and there were no defects or leaks found.The instructions for use for the hydropicc (ls-049), which is printed and provided with each kit, has the following precaution: "do not use sharp instruments near the extension tubes or catheter shaft." avi works with argon medical devices to kit, sterilize, and ship our products to customers and both catheters reported by (b)(6) were from the same argon lot.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.Since (b)(6) had discarded the catheter pouches prior discovery of the leaks, avi is unable to determine which specific avi catheter lot(s) were used in these occurrences.For this investigation, all three internal catheter lot lhrs were reviewed.During processing of each lot, a leak test is required to be performed on each catheter per pr-063 glycerol absorption and leak test rev f.Each catheter is connected to a manifold to allow pressure to flow at 43 psi while they are submerged in glycerol solution.Presence of bubbles along the catheter or suture wing indicates a leak in the catheter and would cause it to be rejected from the lot.As part of the investigation, it was verified that 100% of the catheters were leak tested for each of these three lots.Investigation of the returned catheter clearly indicates that the imperfections on the catheter were caused by a sharp blade from the outside of the catheter.Since none of the unopened kits revealed any defects and there have been no other complaints of leaks from other customers who have received this lot, it is believed that the user for this case inadvertently cut the catheter during preparation or insertion of the device despite the precautions in the ifu.(b)(4).The only effect reported was an underdose of vancomycin.

• Brand Name: HYDROPICC
• Type of Device: 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: 16158462
• MDR Text Key: 307298669
• Report Number: 3015060232-2023-00002
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00862559000487
• UDI-Public: (01)00862559000487
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/11/2024
• Device Model Number: PICC-142
• Device Catalogue Number: 80001004
• Device Lot Number: 11423949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other