MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number PICC-142

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hydropicc replaced an unknown picc device (not a hydropicc), which migrated into the patient's axillary vein, occluding that vein and causing a clot and phlebitis in his right arm; the picc had been implanted for 4 days.The hydropicc was replaced on the same day with another hydropicc into the left brachial vein, and secured with a 5fr securacath.No issues were noted with the replacement procedure.A review of lot #09032001, including the associated lot release data, was performed and did not reveal any notations, comments, or issues, which could be attributed to the cause of the reported problem.The complainant has indicated that the suspect device is being returned for analysis; however, the device has not been received yet.

Event Description

It was reported that, 1 day after being implanted, the hydropicc was unable to be flushed, and that a guidewire could not be advanced through the entire length of the catheter.The catheter was explanted where a knot was observed at the distal end of the catheter.

Manufacturer Narrative

Although several attempts were made to retrieve the suspect device, it has not been returned for evaluation.Therefore, the reported complaint could not be confirmed and a root cause could not be determined.

• Brand Name: HYDROPICC
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford MA 01730 1459
• MDR Report Key: 10684564
• MDR Text Key: 217727133
• Report Number: 3015060232-2020-00005
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)210924(10)09032001
• Combination Product (y/n): Y
• PMA/PMN Number: K193015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: PICC-142
• Device Catalogue Number: PICC-142
• Device Lot Number: 09032001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other