MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	H965750151
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No investigation or device history review required as end user hospital has indicated that there was not a device malfunction and that the migration of the guidewire was due to user technique / error on the part of the rn placing the device.The directions for use provided with the device provide guidance on product placement.Additionally the angiodynamics sales representative has since provided additional product instruction to the rn involved in this event.(b)(4).Device retained by hospital.
Event or Problem Description
Patient presented to the ed for evaluation of a potentially clotted picc.A determination was made that a new device would need to be placed.The picc access rn was called for placement.During placement, guidewire, which had been inserted into peelable sheath, was not secured by the nurse and migrated into the patient's vasculature.A chest x-ray was taken, cv surgery was consulted and the patient was admitted to the hospital.Surgical intervention was performed the following morning, and the guidewire was successfully removed percutaneously.Conversation with the hospital quality manager has indicated that this is being considered an error in technique by the rn.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6113430
• Report Number: 1317056-2016-00163
• Device Sequence Number: 10949462
• Product Code: LJS
• UDI-Device Identifier: H965750151
• UDI-Public: H965750151
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/20/2016

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: Nurse
• Device Expiration Date: 05/31/2017
• Device Model Number: H965750151
• Device Lot Number: 4888117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/18/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 88