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

Model Number	PICC-142
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford, ma
• MDR Report Key: 10145379
• Report Number: 3015060232-2020-00002
• Device Sequence Number: 16753697
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)200522(10)04172001
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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