MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS/SMART PORT; PORT & CATHETER, IMPLANTED

Catalog Number	H787CT66LTPD0
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.There have been no previously reported complaints for packaging lot 5402975 or purchased catheter component lot {652582} and port component lots (5402985) for similar issues.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "patient infection." no adverse trend was indicated.The port which was removed from the patient was discarded at (b)(6) hospital.The angiodynamics bio-sterility manager has reviewed the sterile load records for the reported port lot and confirmed that no abnormalities were noted regarding the sterility processing and that the appropriate procedures were followed.While the exact cause of the infection experienced by the patient is unable to be determined, all records indicate that the angiodynamics smart port was manufactured and sterilized according to specification and there is no reason to believe the condition of the port as it was received at the hospital would have caused or contributed to the reported infection.(pr21961).
Event or Problem Description
Angiodynamics was notified through a letter from a patient that they experienced a bacterial infection after a smartport was implanted in their chest on (b)(6) 2019 at imaging healthcare specialists in ca.The patient was admitted to (b)(6) hospital on (b)(6) 2019 and the port was removed after two sets of blood cultures were drawn an were positive for coliform bacterial.Dna screen was positive for klebsiella.Patient had been undergoing frequent infusion therapy for chronic lyme disease, consisting of ozone, glutathione, heavy metals and other alternative therapies.Port had been accessed twice, most recently on (b)(6) for oxone infusion, at which time he developed severe rigors, low-grade fever.

• Brand Name: ANGIODYNAMICS/SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8518307
• Report Number: 1317056-2019-00055
• Device Sequence Number: 1515349
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 10/31/2021
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 5402975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: 64 YR