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

Catalog Number	H787P12155K0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device from the reported event has been returned to angiodynamics, however the device evaluation has not been completed.Upon conclusion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6) regarding an implanted vortex port: which had been placed on (b)(6) 2017: "presence of perforation in the proximal part of the catheter, in a segment under the catheter connection stem to the reservoir.Patient presented overflow of the medication and bulging at the catheter site.A contrast examination was carried out, and it confirmed the presence of perforation in the catheter." the port was removed and replaced 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 vortex port product family and the failure mode "catheter fractured." no adverse trends were identified.Returned for evaluation was one vortex port with blue boot attached to catheter tubing but not connected to the port outlet tube.Upon removing the blue boot from the catheter tubing a fracture in the tubing was observed in the 15.7-16.0 cm mark.The fracture is a slice-hole in the tubing.When connecting the blue boot to the port outlet tube the fracture is located in the area where the tubing exits the blue boot.The appearance of the fracture is similar to that of a tubing that has been over-pressurized, i.E.Slice is parallel to tubing lumen.The id amd od of the catheter tubing were taken with pin gauges and found to meet specification.The customer's reported complaint is confirmed for catheter tubing fracture.A longitudinal fracture was observed in the tubing in the location where the tubing exits the blue boot.Given the longitudinal appearance of the fracture, the likely root cause is over-pressurization of the catheter tubing.This may have occurred if lumen was occluded and injection/flushing was attempted.The directions for use supplied with the device instructs the physician/clinician on how to properly flush the catheter/port.Angiodynamics manufacturing process controls for the vortex port include air leak immersion testing as well as visual and tensile force testing of the catheters.(b)(4).

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6705196
• Report Number: 1056436-2017-00094
• Device Sequence Number: 1570362
• Product Code: LJT
• UDI-Device Identifier: H787P12155K0
• UDI-Public: H787P12155K0
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H787P12155K0
• Device Lot Number: 4777957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 MO