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	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device history records review was conducted since there was not reported lot number.A ship history review was not possible because of the age of the device (pre-2012 and shipped out of (b)(4)).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 fo 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: "explant from gs [general surgery].Angiodynamic right chest port via ij.Serious resistance to removal along with discoloration and rough surface.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: 7534214
• Report Number: 1317056-2018-00069
• Device Sequence Number: 1512935
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: Physician
• Device Catalogue Number: H787CT66LTPD0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/22/2018
• 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: Required Intervention