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

Catalog Number H787CT80STPD0-US

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2018

Event Type  Injury  

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 and the failure mode "catheter fractured." no adverse trend was indicated.Returned for evaluation was the smartport body with approximately 7 cm of the catheter tubing attached to the port.The portion of the catheter which had fractured off was not returned.As reviewed, the catheter has been trimmed and attached to the port at the 21 cm mark.The blue boot was in place.Septum has multiple puncture marks.Catheter is stained and severed at the 14 - 13 cm mark, 7 cm from the port.There were longitudinal cracks at the severed location.The catheter was highly discolored at the severed location.When the catheter was cut at the 17 cm mark for a dimensional check, the od and od were found to be within specification.Although no definite root cause could be identified, the catheter broke about 7 cm away from the port.The cracked appearance suggests flexural fatigue failure of the tubing.Given the location of the fracture from the port housing (~7 cm) the likely root cause of the crushed/fractured tubing is pinch-off syndrome.The rest of the catheter was found to be normal in appearance and measured within specification.The issues of flex failure as well as pinch-off syndrome are cautioned in the directions for use which is provided with the device.Angiodynamics manufacturing process controls for the port/catheter assembly include air leak testing, catheter tensile force testing and measurements of the tubing id and od.((b)(4)).

Event Description

As reported, the patient had been receiving chemo treatment.On (b)(6) 2018 when the port was unable to be flushed, the patient was sent to imaging and there was noted to be a fragment of catheter in the left chest.The patient was taken to surgery and the port as well as the attached part of the catheter was removed.A new port was placed.On (b)(6) 2018 the patient had the remainder of the catheter removed.The used device has been returned to angiodynamics for evaluation.

• 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: 7369525
• MDR Text Key: 103423513
• Report Number: 1317056-2018-00030
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2018

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
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H787CT80STPD0-US
• Device Lot Number: 5066552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR