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

Model Number	PICC-142
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford MA 01730 1459
• MDR Report Key: 10684564
• Report Number: 3015060232-2020-00005
• Device Sequence Number: 4123114
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)210924(10)09032001
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other