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

Catalog Number	H787CT75STSA0
Medical Device Problem Codes	Crack (1135); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has not yet been indicated whether the used device will be returned to angiodynamics for evaluation.The australian distributor is working to obtain the sample as well as additional details of the event.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6): incident at a children's hospital - "the surgeon advised that the catheter snapped at the level of the clavicle - the catheter piece was found in the pulmonary artery.The patient required emergency theatre, angiogram and removal of the smart port." angiodynamics is attempting to obtain the used device for evaluation.
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 may 2018 angiodynamics complaint report was reviewed for the smart port product family and the failure mode "catheter fractured/migrated." no adverse trend was identified.As received, the catheter tubing was fractured near the 9cm mark.The catheter was measured (id and od) and found to be within specification.The reported complaint has been confirmed.Although no definite root cause could be identified, the catheter broke about 9 cm away from the port.There is a jagged portion of the fracture that is consistent with a flexural failure of tubing.The location of fracture from the port and the nature of the fracture indicate "pinch-off syndrome" as likely root cause for this event.Pinch-off syndrome is cautioned against in the device directions for use.((b)(4)).

• 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: 7398687
• Report Number: 1317056-2018-00039
• Device Sequence Number: 11091302
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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 Expiration Date: 03/31/2017
• Device Catalogue Number: H787CT75STSA0
• Device Lot Number: 5012655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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