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

Catalog Number	H787CT75STSA0
Medical Device Problem Codes	Crack (1135); Migration (4003)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used port / catheter has not yet been returned to angiodynamics; however, follow-up efforts to obtain the device are continuing.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4) regarding an implanted port: "the port had been in-situ for 6 months when the patient had to have some of the catheter removed from his heart.The port was still firmly planted in its original position with approximately 10-12 cm of catheter attached".Further details: the patient reported bruising in the port area on (b)(6) 2018.He presented to the emergency department with increased bruising and pain on (b)(6) 2018.Removal of the port and implantation of another port was completed on (b)(6) 2018.The migrated catheter was located in the right atrium.Implantation method was subclavian.There was no patient injury.The explanted port has been kept for investigation (the distributor is attempting to obtain the port for return to angiodynamics).
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 may 2019 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured/migrated." no adverse trend was identified.The distributor returned the port with approximately 11cm of catheter tubing attached to the port.The distal tip portion of the catheter tubing was not returned.Bio material was noted to the inside of the port and catheter tubing.The catheter appeared oval/squashed at the fracture site, however the rest of the catheter was found to be normal in appearance.The catheter id and od were measured and were found to be within specification.The likely root cause of the fracture in the catheter tubing is repeated pinching/flexing of the tubing (flexural failure), i.E., pinch-off syndrome.The jagged and pinched nature of the tubing fracture, as well as the 11cm distance from the port body are all indicators of pinch-off syndrome.The directions for use supplied with the smartport device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome".(b)(4).

• Brand Name: ANGIODYNAMICS / SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8326032
• Report Number: 1317056-2019-00030
• Device Sequence Number: 14016724
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSA0
• UDI-Public: H787CT75STSA0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: H787CT75STSA0
• Device Lot Number: 5272511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: 55 YR