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

Model Number	MID-141
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hydromid was unable to aspirate or flush.When the line was removed, it was noted that an area of the catheter experienced fatigue and another area had burst.
Additional Manufacturer Narrative
On (b)(6) 2022, a nurse attempted to place a hydromid in an obese female patient and experienced difficulty getting the entire midline (pre-cut) to the measured tip location; it stopped after approximately 10cm*.The midline was removed, and a wire (not provided by avi) was inserted to confirm that the introducer was in the vein.The midline was then trimmed further and reinserted successfully.Brisk blood return and an easy flush was confirmed.On (b)(6) 2022, the nurse reported that the patient went to mri and power injection was to be used.Mri stated in their notes that they could not flush the hydromid, and a new line (not provided by avi) was placed in the patient's opposite hand for the mri.When eddie korycka (avi's clinical field director) arrived on site to discuss the reported complaint, the nurse stated that the line was flushing with difficulty.The lead clinician on the iv team, sean lau, attempted to flush and experienced a lot of resistance.The catheter was slowly pulled out while aspirating for blood return with no success.Upon removal, there was a burst noted in the distal third of the catheter.There was also a fatigued area at a section in the proximal half of the catheter.The iv team disposed of the catheter and the patient needed no other intervention.Due to the initial obstruction noted and the reported patient anatomy, the line may have been pinched off or occluded prior to power injection.If this did occur, an attempt at power injection may have contributed to the fatigue at the upper portion of the catheter and the burst at the lower third.This is unable to be confirmed, however, since the device was not returned to avi for investigation.The attending team should have acknowledged that the patient had the following contraindication, per the ifu (ls-015): anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.

• Brand Name: HYDROMID
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ACCESS VASCULAR INC.; 749 middlesex turnpike; billerica MA 01821
• Manufacturer Contact: brian hanley ; 749 middlesex turnpike; billerica, MA 01821 ; 7815386594
• MDR Report Key: 15000408
• Report Number: 3015060232-2022-00001
• Device Sequence Number: 1881081
• Product Code: FOZ
• UDI-Device Identifier: 00850030354020
• UDI-Public: 00850030354020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203069
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 09/29/2023
• Device Model Number: MID-141
• Device Catalogue Number: 80004004
• Device Lot Number: 11411212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: Female