MAUDE Adverse Event Report: PFM MEDICAL ANGIODYNAMICS / VORTEX; PORT & CATHETER IMPLANTED

Catalog Number	H965451840
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Angiodynamics is in the process of finding out whether the device sample will be returned.As this port is a purchased component, the manufacturer, pfm medical has been made aware of the event and will be responding via a supplier corrective action request (scar).The sample, if it becomes available, will be forwarded to pfm for evaluation.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).
Event or Problem Description
As reported by hospital on user medwatch # (b)(4): "event description: during port removal procedure it was noted tubing was not connected to the port - no evidence of tubing in canal or in neck area.X-ray revealed tubing located in right ventricle.Patient required additional procedure to retrieve tubing.What was the original intended procedure? - port removal." further information received from the hospital indicated that the port had not been accessed at the hospital since (b)(6) 2017.The patient reported that it had been "accessed locally in (b)(6) 2017 without issue." the port was being removed because of end-of-treatment.It has not been confirmed yet as to whether the device will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot (130823 000) for item number h965451840 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 rcent angiodynamics complaint report was reviewed for the xcela ports {pfm} product family and the failure mode "catheter detached/migrated." no adverse trend was identified.Although the device sample was not returned for evaluation, angiodynamics notified the port supplier/manufacturer, pfm medical of the event via a supplier corrective action report (scar).Pfm performed a device history records review and verified that there were no quality or manufacturing non-conformances noted for this lot.Without a sample analysis, the exact cause of the reported event was unable to be determined.(b)(4).

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER IMPLANTED
• Manufacturer (Section D): PFM MEDICAL; 1815 aston ave.; suite 106; carlsbad CA 92008
• MDR Report Key: 6913281
• Report Number: 1317056-2017-00080
• Device Sequence Number: 1408819
• Product Code: LJT
• UDI-Device Identifier: H965451840
• UDI-Public: H965451840
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: Other Health Care Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: H965451840
• Device Lot Number: 130823000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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
• Patient Age: 40 YR