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

Catalog Number	H787CT96STSD0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used device has been returned to angiodynamics however the evaluation has not been completed.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by the patient: had a port surgically implanted on (b)(6) 2016.The patient was scheduled for a series of eight chemotherapy treatments.The first treatment was (b)(6) 2017.Four weeks after the second treatment ((b)(6) 2017) the patient saw her physician and had an x-ray which showed that the catheter had broken and traveled to the right ventricle.On (b)(6) 2017 the physician retrieved the pieces of broken catheter through a vein in the patient's neck.The port was (scheduled to be) removed on (b)(6) 2017.
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 june 2017 angiodynamics complaint report was reviewed for the smart port product family and the failure mode "catheter fractured." no adverse trend was identified.The used port was received with the blue boot attached to the port outlet tube/catheter.The distal tip of the catheter tubing was fractured at the ~14cm mark; the fractured end was jagged/crushed, i.E.Similar in appearance for tubing with "pinch off".The catheter was connected to the port outlet tube at the 20-21cm marks.The fracture in the catheter tubing occurred ~6-7cm from the port, which is also consistent with "pinch-off".The distal portion of the catheter tubing was not returned.The blue boot was observed with surface damage likely caused by scalpel or other similar sharp object.Dimensional inspection: the catheter tubing was cross-sectioned near the fracture (~15cm mark); cross-sectioned did not show any out-of-round or thin wall issues.Dimensions of the catheter tubing were taken at this location and were found to be within specification.The appearance of the fractured end of the tubing was jagged/crushed.This type of catheter fracture and its location from the port are consistent with "pinch-off syndrome".The directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome," a potential complication.(b)(4).

• Brand Name: ANGIODYNAMICS / SMART PORT CT
• Common Device Name: PORT / CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6639971
• Report Number: 1056436-2017-00086
• Device Sequence Number: 1122837
• Product Code: LJT
• UDI-Device Identifier: H787CT96STSD0
• UDI-Public: H787CT96STSD0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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: 09/30/2019
• Device Catalogue Number: H787CT96STSD0
• Device Lot Number: 5083681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 07/26/2017
• 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