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

Model Number PICC-142

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, a follow-up phone conversation with mr.(b)(6) described the patient conditions as "high bmi" and "large deep veins." in addition, the clinician stated that on (b)(6) 2020 he noted that the catheter was "out 2 cm" (extending outside the patient).The clinician stated that they cleaned, re-hydrated, and re-inserted the catheter without issue; however, on (b)(6) 2020, the hydropicc was leaking, and was subsequently replaced with a non-hydropicc device.It was mr.Bunch's opinion that the cause of the kink and crack was due to either the patient snagging the device on something, or due to manipulation of the device or the patient, likely during a dressing change.The clinician stated that the hydropicc was implanted on (b)(6) 2020 without issue, and "excellent blood flow" was confirmed at the completion of the procedure.

Event Description

It was reported that the clinician was notified that the hydropicc "wasn't working, repositioning the infusion resulted in leaking at site." when the clinician arrived on site, they "sutured cut line pulled back at [sic] found to be kinked and cracked at the suture wing stem/catheter junction.".

• Brand Name: HYDROPICC
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford, ma
• Manufacturer (Section G): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford, ma
• Manufacturer Contact: kenneth hirakawa ; 175 middlesex turnpike; suite 1a; bedford, MA 01730-1459 ; 7815386594
• MDR Report Key: 10145379
• MDR Text Key: 196168017
• Report Number: 3015060232-2020-00002
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)200522(10)04172001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: PICC-142
• Device Catalogue Number: PICC-142
• Device Lot Number: 04172001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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