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

Catalog Number	H787CT66LTPD0
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
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.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter difficult removal." no adverse trend was indicated.The end user hospital's reported complaint description of difficult removal along with discoloration and rough catheter surface could not be confirmed as no sample was returned.Without receiving product for evaluation we are unable to definitively determine a root cause for this incident.Fibrin formation is a potential complication listed in the device directions for use.Patient anatomy and drugs used during treatment may have contributed to the reported issues.(b)(4).
Event or Problem Description
As reported by hospital regarding a smart port: "moderate resistance to traction on the catheter was encountered.As the catheter was removed a strip of fibrin sheath at least two cm long was removed with it.The catheter was rough and discolored." no device will be returned.No patient injury.

• 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: 7669301
• Report Number: 1317056-2018-00140
• Device Sequence Number: 1018516
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: No Information
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 4909410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1