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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 09mar2023,, (b)(6) (rgv piccs llc) called (b)(4) to report a rupture in a picc line.No additional information was provided at this time, but (b)(6) indicated that he kept the device and would send it back to avi for further investigation.A returned goods authorization (rga-005) was issued and avi received the return on 04 apr, 2023.Several attempts were made by (b)(4) to obtain additional information from (b)(6) about the complaint issue.Attempts were made on (b)(6) 2023, (b)(6) texted (b)(4) to state that he was "too busy" to provide all the requested information and instead noted the following: "the line was reported clogged.The nursing home called me to troubleshoot it.I decided to replace without troubleshooting and when i flushed the line on the table tray i could see it was ruptured." avi performed an investigation on the returned device on 04 apr 2023.The overall catheter length was 18cm from the suture wing and an opening was observed approximately 4.4cm from the suture wing.When the catheter was flushed, ~70% of the flow came through the opening and ~30% came through the distal tip.The catheter was then dissected and a partial occlusion was found, starting approximately 12cm from the suture wing and extending 18cm from the suture wing (~6cm in length).The opening of the catheter does not have the characteristics typically seen when a catheter bursts (deformed and/or stretched catheter walls originating from inside the catheter); rather, it appears to be a straight cut originating from the outside of the catheter.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." (b)(6) did not provide the lot number of the device, however, avi was able to identify it as lot #11423949 as this is the only lot of picc-142 products (hydropicc max barrier) that had been shipped to (b)(6) prior to the complaint aware date.This lot number is assigned by argon medical (avi's approved supplier for kitting).This kit contained catheters from three different avi catheter lot numbers: #10212102, #11232101, and #11092101.For this investigation, all three lhrs were reviewed.During processing of each lot, a leak test is performed per pr-063 glycerol absorption and leak test rev f.Each catheter is connected to a manifold, five at a time, to allow pressure to flow at 43 psi while they are submerged in glycerol solution.The presence of bubbles along the catheter or suture wing indicates a leak and would cause the catheter 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.In summary, investigation of the returned device indicates that the opening observed in the catheter wall was likely caused by a sharp blade from outside the catheter.It is believed that the user for this case inadvertently cut the catheter during preparation or insertion of the device despite clear precautions in the ifu.
Event or Problem Description
Customer reported a "ruptured" picc line.

• 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: 16700696
• Report Number: 3015060232-2023-00006
• Device Sequence Number: 20251405
• Product Code: LJS
• UDI-Device Identifier: 00862559000487
• UDI-Public: (01)00862559000487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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: 01/08/2024
• 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: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/07/2023
• 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