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

Model Number	45885
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
Event 2 of 2 (same patient) reference (b)(4), 1317056-2021-00069 for first event.The distributor reported the same patient had an issue with the second bio-stable 4f sl-55cm placed.It was reported the same issue occurred; during injection of contract medium (4ml/sec) for a ct scan, the picc dislodged/misplaced from the vena cava into the subclavian vein.Ultimately, the picc was removed and replaced.There was no report of patient harm or adverse event as a result of this incident.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer supplied x-ray images; review of the mages were inconclusive.The customer's reported complaint description of picc dislodged/misplaced from the vena cava into the subclavian vein cannot be confirmed.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the reported packaging and component lots 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).

• Brand Name: BIOFLO PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11612796
• Report Number: 1317056-2021-00074
• Device Sequence Number: 19614023
• Product Code: LJS
• UDI-Device Identifier: H965458850
• UDI-Public: H965458850
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: No Information
• Device Model Number: 45885
• Device Catalogue Number: 45885
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR