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

Catalog Number	H787PSAX10I0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device history records review was conducted since there was no reported lot #.A ship history review was not performed since port was manufactured 9.5 years ago and it is unknown at what hospital the port was placed.The recent angiodynamics complaint report was reviewed for the vortex port product family and the failure mode "catheter fractured." no adverse trend was identified.As received, the catheter tubing {9cm} and collar were detached from the port, with a small portion of catheter remaining on the port stem.The detached portion of the catheter was measured (id and od) and found to be within specification.The stem the catheter onto was measured (od) and found to be within specification.The locking sleeve that holds the catheter onto the stem was measured (id) and found to be within specification.The customer's reported complaint description was confirmed for catheter tubing fracture.The fracture was located at the 9cm mark on the catheter tubing (9cm from the port) and was jagged in appearance.A fracture of this type in this general location from the port is indicative of a flexural fatigue failure, similar to that of pinch-off syndrome.Although the exact root cause of the catheter fracture was unable to be determined, it is unlikely to have been manufacturing-related, as the catheter functioned successfully for 9.5 years.No manufacturing non-conformances or out of specification conditions were observed during the sample evaluation.The directions for use provided with the device contain guidance on port placement and maintenance.Potential complications such as catheter fragmentation and catheter pinch-off are reviewed.((b)(4)).
Event or Problem Description
As reported, vortex port had been implanted since (b)(6) 2008.Upon explant in (b)(6) 2018 the catheter fractured and had to be retrieved and removed (snared) by an interventional cardiologist.The used device was returned to angiodynamics for evaluation.No additional patient complications were reported.

• Brand Name: ANGIODYNAMICS / VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7286507
• Report Number: 1317056-2018-00014
• Device Sequence Number: 1827433
• Product Code: LJT
• UDI-Device Identifier: H787PSAX10I0
• UDI-Public: H787PSAX10I0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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
• Operator of Device: Physician
• Device Catalogue Number: H787PSAX10I0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/21/2018
• 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