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

Model Number MID-141

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/10/2023

Event Type  Injury  

Event Description

Customer notified avi via text that said, "got a mid that split." the accompanying photo revealed a defect in the catheter wall that appeared to be leaking fluid.

Manufacturer Narrative

On (b)(6) 2023, (b)(6) sent a text message to (b)(6) that said he had a midline that "split." he also sent a photo that appeared to show a defect in the catheter wall that was leaking fluid.See attachment 1.(b)(6) agreed to send the catheter back for evaluation at avi and provided the following additional information via e-mail: the line was implanted on (b)(6) 2023 for non-vesicant antibiotics.The line was explanted on (b)(6) 2023 after blood return could not be achieved; it was removed and replaced without incident and there was no further impact to the patient.It is unlikely that the line was power injected, as the patient was in a nursing home.Avi received the midline back on (b)(6) 2023 and (b)(6) performed an investigation on the device.A pinhole leak was found 44mm from the suture wing, approximately near where the taper region on the catheter ends.See attachment 2 for approximate location.The area immediately surrounding the pinhole appeared to have fatigued/stretched, and the failure appeared to have originated from inside the lumen.Using image analysis software, the hole opening was measured at roughly 0.006" in diameter while the fatigued area was about 0.019" in diameter.See attachment 3.The catheter was flushed and the leak was confirmed.While handling the catheter, it was noticed that near the location of the hole there was a "material memory" that suggests the catheter was kinked for a period of time.The catheter was then dissected.Staining was observed on the inner walls of the lumen, but no occlusions were found.See attachment 4.The reported lot #11435835 is assigned by argon medical (avi's approved supplier for kitting).This kit contained catheters from three different avi catheter lot numbers: #04052201, #04182202, and #01132201.For this investigation, all three lhrs were reviewed.During processing of each lot, a leak test was performed per pr-063 glycerol absorption and leak test.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.This step was completed for each of the three lots.In summary: no occlusion was found in the catheter.It is unlikely that the defect occurred prior to placement since avi performs 100% leak testing on all catheters and there were no clinical signs or symptoms of an issue until four days after implanting the device.There was evidence of a kink that occurred near the site of the leak.The most likely root cause is a kink in the catheter that occurred after placement.This may have caused a blockage in the lumen, leading to a rupture in the catheter wall.

• 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: 17079216
• MDR Text Key: 316747710
• Report Number: 3015060232-2023-00007
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00850030354020
• UDI-Public: (01)00850030354020
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: MID-141
• Device Catalogue Number: 80004004
• Device Lot Number: 11435835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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