MAUDE Adverse Event Report: ACCESS VASCULAR INC. HYDROMID; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number MID-141

Device Problem Insufficient Information (3190)

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

Event Date 01/22/2023

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2023, (b)(6) (avi area sales manager) received a photo of a ruptured mid-141 catheter from (b)(6) of kc vatco.(b)(6) threw away the midline right after taking the photo was taken, so the device was not available for return or further evaluation.Avi solicited (b)(6) for information on 25jan2023, 27jan2023, and 17feb2023.(b)(6) provided additional details on 21feb2023.He noted the following: on (b)(6) 2023: the line was hydrated per recommendations and placed.15cm long, 0cm external.On (b)(6) 2023: the line was unable to be flushed.The line was then pulled back to 1cm external and was able to be flushed by the nurse.On (b)(6) 2023: the line was again unable to be flushed.An assessment was done by (b)(6), and the line appeared to be kinked 5-6cm from the hub.This was verified via ultrasound.(b)(6) performed an over-the-wire exchange and the guidewire met resistance upon insertion.(b)(6) pulled the line out further to assess, and a bulge/rupture of the catheter was observed approximately 4-5cm from the hub.The catheter tip was patent.The facility flushes bid (twice a day) and prn (as needed).The line was being used for zosyn and was not power injected.There was no adverse event for the patient and they were discharged to another facility two weeks later.(b)(6) also noted that he experienced two additional failed lines from the same lot due to kinking near the insertion site but did not report any additional ruptures.Per (b)(6) (avi clinical field director), kinking does not typically occur when the line is placed correctly.It is possible that someone may have migrated the catheter accidentally during a dressing change and tried to push it back up into the arm, causing a kink, but it cannot be confirmed.A kink in the catheter can cause a blockage and, if too much pressure is applied during flushing, could cause a rupture in the catheter wall prior to that kink.Argon medical devices is a contract manufacturer for avi.Part of argon's process for kitting our products is to accept avi lots and convert them into their own.Avi was able to identify the associated argon lot number (#11423948), as only one lot has been shipped to (b)(6) to date.This lot was associated with six avi catheter lot numbers: #10122101, #11042102, #12092103, #11162103, #12162105, and #11242103.For the purposes of this investigation, since avi is unable to identify which specific avi lot number the catheter that ruptured came from, the lhrs for all six avi lots were reviewed.No anomalies or deviations that could have contributed to the complaint issues were found.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 lots.

Event Description

Midline experienced difficulty during flushing.Removal the following day revealed a bulge and rupture of the catheter.

• Brand Name: HYDROMID
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS 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: 16437133
• MDR Text Key: 310176964
• Report Number: 3015060232-2023-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203069
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/23/2023
• Device Model Number: MID-141
• Device Catalogue Number: 80004004
• Device Lot Number: 11423948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other