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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2023, (b)(6) (rn at epicc (b)(6)) notified (b)(6) (avi area sales manager) of a hydropicc that had "ruptured." she sent an image, which appears to show a defect in the catheter wall.See attached.Avi followed up with (b)(6) to obtain additional information and received the following details on (b)(6) 2023: - the line was implanted on (b)(6) 2023.- the line was explanted on (b)(6) 2023 (dwell time of 16 days) after the line would not flush or draw blood.- the lot number was #11423949 (hydropicc 4fr single lumen - maximal barrier kit).- there was no impact to the patient.- the line was not power injected.- the customer did not know if there were any signs of an occlusion or kinking.- the customer indicated that the line was hydrated and flushed according to the ifu.- the line was discarded after the attached photo was taken, and therefore it is not available for return to avi.The lot number provided (#11423949) 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 was 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.This step was completed for each of the three lots.Since all catheters are leak tested at avi and there were no clinical signs or symptoms until 16 days after insertion, it is likely that the defect in the catheter wall occurred sometime after insertion.Without return of the device, avi is not able to investigate further or identify a potential root cause.
Event or Problem Description
Customer reported a ruptured hydropicc.

• 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: 17969817
• Report Number: 3015060232-2023-00009
• Device Sequence Number: 20750643
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/19/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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: Unknown