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

Catalog Number	H965750171
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used guidewire has been returned.As this is a purchased device for angiodynamics, it will be forwarded for evaluation, along with a scar (supplier corrective action request) to the supplier, neometrics.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).The initial mdr for this complaint record was originally submitted on 02/17/2016 via usps.Due to e-submitting requirements, it was not accepted.Per request, this initial mdr report is being submitted via the esubmitter program.The original mdr has been attached for reference.
Event or Problem Description
As reported: "nurse was placing a bedside picc.After gaining access with the green needle, the nitinol wire wouldn't thread.She pulled the wire & the needle.She tried to gain access in the same arm in a different location of the brachial vein.She gained access with a different needle (the safety needle) and reinserted the wire.The wire had resistance again and she couldn't advance.She ended up pulling the wire and it started to unravel.By the time she pulled the wire out, the tip was completely unraveled and part of the wire broke off into the patient.She was able to retrieve the broken part of the wire, but when they took an image, they found out that a part of the wire was lodged in the patient's arm.Due to the fact that the wire wasn't lodged in the vessel, they decided not to attempt to remove it.The account had to scrap this kit and open another kit to place a picc in the other arm.".

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny 12801, ny ; 7424488
• MDR Report Key: 6396261
• Report Number: 1317056-2016-00035
• Device Sequence Number: 2433251
• Product Code: LJS
• UDI-Device Identifier: H965750171
• UDI-Public: H965750171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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 Expiration Date: 12/31/2017
• Device Catalogue Number: H965750171
• Device Lot Number: 4971820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 03/10/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2016
• 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
• Patient Age: 77 YR
• Patient Sex: Female