MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / SMART PORT; PORT / CATHETER

Model Number H787CT80STPD0

Device Problems Crack (1135); Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Pneumonia (2011); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

As no lot number was reported, a ship history report (shr) was generated for item number h787ct80stpd0 in order to determine the last three lots shipped to the reporting hospital 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.In addition, the corresponding lots for purchased component (catheter) were 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 february 2018 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured / migrated." no adverse trend was identified.The reported complaint description cannot be confirmed as no sample was returned for evaluation.Although the exact root cause is unable to be determined, a potential root cause for the catheter fracture may be due to "pinch off syndrome".The directions for use supplied with the smartport device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome".(b)(4).

Event Description

As reported the port was a right ij placement on (b)(6) 2016.Per records obtained from the hospital with the patient's permission: on (b)(6) 2017, the patient presented to the emergency room after having experienced a pain in her chest, shortness of breath (copd), fever.Diagnosed with pneumonia, and acute hypoxic respiratory failure.Fluoroscopy determined that the catheter had fractured and migrated.The patient was transferred to a different hospital (b)(6) for removal of the port and catheter.The catheter fragment was removed via snare from the right atrium/right ventricle.

• Brand Name: ANGIODYNAMICS / SMART PORT
• Type of Device: PORT / CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 7400453
• MDR Text Key: 104525288
• Report Number: 1317056-2018-00034
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: H787CT80STPD0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR