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

Catalog Number	H787CT96STSD0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	12/01/2018
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.The recent angiodynamics complaint report was reviewed for the smartport product family for the failure modes "patient infection" and "hole in catheter." no adverse trends were identified.Additionally, this is the only reported complaint for this failure mode in the past 15 months for the smartport product family.The end user's report of a hole in the catheter was unable to be confirmed, nor could a potential root cause be determined, as no device was returned for evaluation.A review of the sterilization records was performed and no non-conformant issues were associated with the sterile load for the reported packaging lot.The directions for use (dfu) packaged with the smart port provides guidance on implantation, maintenance and use.(b)(4).
Event or Problem Description
As reported, portacath was placed on (b)(6) 2018 for chemotherapy due to lung cancer.First chemo treatment was on (b)(6) 2018 and that went fine.On (b)(6) 2018 the patient was admitted with sepsis and infection "due to portacath." "that same day they removed the portacath and then upon removal of the port a tiny pinpoint perforation was present along the proximal aspect of the catheter.The leak was discovered upon removal of the port and then injection under pressure while kinking the end of the catheter.The tip was sent for culture which was (b)(6) for (b)(6)." additional information received from the risk manager indicates that the physician (dr.(b)(6)) "checks the ports before they get placed.He found no holes orpuncture marks at the time of placement.He believe this is possibly a user error where the port was entered." the port from the reported event was discarded/not returned to angiodynamics.

• 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: 8262201
• Report Number: 1317056-2019-00011
• Device Sequence Number: 13779665
• Product Code: LJT
• UDI-Device Identifier: H787CT96STSD0
• UDI-Public: H787CT96STSD0
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 09/30/2021
• Device Catalogue Number: H787CT96STSD0
• Device Lot Number: 5385566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/18/2019
• 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: Required Intervention
• Patient Age: 49 YR