MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROPICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	80001002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 21 september 2022, (b)(6) notified avi of a complaint.(b)(6) reported that a nurse, (b)(6), was consulted for a hydropicc that was leaking.When she determined it was not phlebitis, the catheter was removed and "crack" was observed just distal to the reverse taper.A video was provided showing blood leaking from the catheter just under the skin.An image was also provided to show the suspected crack post-removal.Per request, (b)(6) participated in a phone call on the same day with members of the avi quality team ((b)(4) and (b)(4)).(b)(6) indicated on the call that the hospital record reflects insertion to be 1cm from the suture wing or insertion site (1cm is the recommended insertion on the hydropicc instruction for use).(b)(6) noted that from the video the insertion appears to be approximately 3-4cm from the insertion site.Based on the catheter defect type and location, (b)(6) suspects the additional catheter length outside the insertion site dehydrated resulting in the crack during catheter use.Upon further discussion, it was noted that (b)(6) has had issues with this particular site not following proper care and maintenance procedures in the past, and he suspects that a dressing change was not done properly.After the catheter was removal, a new hydropicc was placed.The lot# of the picc-142 catheter/kit was not provided, therefore, avi is not able to complete an lhr review to review production documentation as part of this investigation.Additionally, there have been no other lots associated with this reported issue.
Event or Problem Description
Hydropicc leaked.When the line was removed, it was noted that the catheter was cracked just distal to the reverse taper.

• 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: 15610413
• Report Number: 3015060232-2022-00004
• Device Sequence Number: 2810120
• Product Code: LJS
• UDI-Device Identifier: 00862559000463
• UDI-Public: (01)00862559000463
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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 Model Number: 80001002
• Device Catalogue Number: 80001002
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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