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

Catalog Number	H787CT75STSA0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Death (1802)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was reported, a ship history report (shr) was generated by angiodynamics' distributor for item number h787ct75stsa0 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5225965, 5254792 and 5254793).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.In addition, the corresponding lots for purchased sheath/dilator component item number 106422 (angiodynamics lot 18485 {sln (b)(4)}, 18486 {sln (b)(4)}, 18487 {sln (b)(4)}, 18488 {sln (b)(4)}}, 18801 {sln (b)(4)} packaged in it.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 (b)(6) 2018 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "sheath / air bubbles." no adverse trend was identified.No device samples have been returned for evaluation and it is not possible to determine the root cause of the event or the relationship been the device and the reported event.The non-valved sheath/dilator accessory used in the reported procedure is supplied to angiodynamics by the supplier (b)(4).(b)(4) has been notified via (b)(4) for informational purposes only, as no sample is being returned.In consultation with angiodynamics' (b)(4) distributor, the hospital is currently exploring options for sourcing a valved sheath for future port implantation procedures.The potential for air embolism is an anticipated procedural complication and the smart port dfu contains guidance regarding recommended use of the sheath/dilator during the port implantation procedure.(b)(4).
Event or Problem Description
(b)(4), angiodynamics' distributor in (b)(4), received an email from a clinical nurse consultant in the medical oncology department of a major hospital in (b)(6).The email stated: we have had an incident recently where a patient received an air embolus from a port insertion.One of the recommendations will be to use valved insertion sheaths, to prevent this occurring again.In a follow-up phone conversation with an (b)(4) representative the clinical nurse consultant also advised: the air embolism resulted in death.An official investigation is underway now and the hospital has decided that using a valved insertion sheath for port placement is required.(b)(6) 2018: (b)(4) attempted to obtain more information from the hospital relating to this adverse event.The hospital has supplied (b)(4) with no further information.
Additional Manufacturer Narrative
Supplemental medwatch being submitted because of notification by the complaint reporter that the patient involved in the procedure did not die (i.E., the reported air embolism was not fatal).The corrected sections are as follows: adverse event outcome: replaced "death" with "intervention required to prevent permanent impairment." reportable event type: replaced "death" with "serious injury." patient code: removed code 1802.All information from original medwatch is still applicable.(b)(4).

• 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: 8086145
• Report Number: 1317056-2018-00204
• Device Sequence Number: 1770516
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSA0
• UDI-Public: H787CT75STSA0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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 Catalogue Number: H787CT75STSA0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 05/16/2019
• 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: Death; Required Intervention