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

Model Number	45668
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the sheath/dilator involved in the reported event is a purchased device for angiodynamics, the sample, along with a supplier corrective action request has been forwarded to the supplier, greatbatch medical.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).** the initial mdr for this complaint record was originally submitted on (b)(6) 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, tabs broke off peelable sheath packaged with xcela picc.End user used hemostats to pull the sheath out of the patient.No patient injury occurred.The used sheath has been returned to angiodynamics.

• Brand Name: ANGIODYNAMICS / XCELA
• 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: 6428466
• Report Number: 1317056-2016-00037
• Device Sequence Number: 16752384
• Product Code: LJS
• UDI-Device Identifier: M001456680
• UDI-Public: M001456680
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45668
• Device Catalogue Number: M001456680
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2016
• Supplement Date Received by Manufacturer: 02/22/2016
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 03/23/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown