MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Model Number	45885
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of picc catheter tip dislocation/malpositioned into the jugular vein during injection cannot be confirmed.No picc sample was returned for evaluation and no x-ray images provided for review.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.In addition, the corresponding lots for (46700128) were reviewed.The angiodynamics component lots reviewed were (5647574, 5648746, 5651380, 5654166 and 5655309).The device history records were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
Event or Problem Description
A distributor reported an issue with a bio-stable 4f sl-55cm.It was reported the picc dislocated [catheter malposition] in the jugular vein, during injection of contract medium.It was reported that the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident but the device was removed.The reported device is not available to be returned to the manufacturer for evaluation.

• Brand Name: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11640821
• Report Number: 1317056-2021-00075
• Device Sequence Number: 3124585
• Product Code: LJS
• UDI-Device Identifier: H965458850
• UDI-Public: H965458850
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: 45885
• Device Catalogue Number: 45885
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1