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

Catalog Number	H787CT66PTPD0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h787ct66ptpd0) in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The device history records for the lots obtained through the ship history report (packaging lots) 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.The recent angiodynamics complaint report was reviewec for the smartport product family and the failure mode "catheter difficult removal." no adverse trend was indicated.The reported complaint description of the catheter being difficult to remove and damaged is not confirmed, as no sample was returned.Although without receiving product for evaluation, we are unable to definitively determine an exact root cause for this incident, it is likely not the result of manufacturing failure as the device functioned appropriately for 4 years prior to being removed.Placement (i.E.Pinch-off syndrome), patient anatomy and drugs used during treatment are potential root causes of this failure.The directions for use packaged with the smart port provides guidance on catheter placement, maintenance and potential complications such as catheter fragmentation and pinch-off syndrome.((b)(4)).
Event or Problem Description
As reported, port which had been implanted for approximately 4 years was removed on (b)(6) 2018 due to completion of treatment for cancer."upon attempted removal, the physician was unable to remove the catheter and noted some potential damage at the site.Patient was refered to interventional radiology.Catheter was successfully removed, but there was some damage to the catheter near where it passed under the subclavian vein." the used device was discarded at the hospital.The patient condition was listed as "stable.".

• Brand Name: ANGIODYNAMICS / SMARTPORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7295655
• Report Number: 1317056-2018-00018
• Device Sequence Number: 13765682
• Product Code: LJT
• UDI-Device Identifier: H787CT66PTPD0
• UDI-Public: H787CT66PTPD0
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

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: H787CT66PTPD0
• 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: 01/31/2018
• Initial Report FDA Received Date: 02/26/2018
• 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
• Patient Age: 7 YR