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

Catalog Number	H787CT75STSA0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the used port will be returned for evaluation, but it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), (b)(6) reported that when accessing a smartport implanted in the chest, swelling to the site was noted upon flushing.It was confirmed by x-ray that the catheter had disconnected / fractured from the hub.The port was explanted on (b)(6) 2017.It had been in place for 3 years, as it was implanted on (b)(6) 2014.The used device will be returned to angiodynamics for evaluation.
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 recent angiodynamics complaint report was reviewed for the smart port product family and the failure mode, "catheter fractured." no adverse trend was identified.The port was returned to angiodynamics with the blue boot attached to the catheter and connected to the port outlet tube.The catheter tubing was attached to the port at approximately the 17cm mark; distal tip end of the catheter tubing was at 2cm mark.The catheter tubing was fractured at the 19cm mark.No damage or manufacturing non-conformance were observed during visual inspection of the port.The three port sutures holes did not appear pierced.Dimensional check: the catheter tubing did not show any out-of-round or thin wall issues.Dimensions of the catheter tubing were taken at the 2cm mark: the id and od dimensions of the catheter tubing distal end were measured and found to meet specification.The reported complaint description is confirmed for catheter tubing fracture at the 19cm mark, where the catheter exited the blue boot.The appearance of the fracture was jagged and suggests the root cause was flexural fatigue of the catheter during the 3 years device was in situ.The rest of the catheter was found to be normal in appearance and measured within dimensional specification for id and od.Based on the location of the fracture at the port body junction and the fracture's jagged appearance, the likely root cause of the failure is flexural fatigue.The directions for use provided with the smart port include guidance on catheter placement location and technique as well as cautions against potential complications such as catheter fragmentation and pinch-off syndrome.((b)(4)).

• Brand Name: ANGIODYNAMICS / SMARTPORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6979233
• Report Number: 1056436-2017-00110
• Device Sequence Number: 16265618
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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 Expiration Date: 03/31/2015
• Device Catalogue Number: H787CT75STSA0
• Device Lot Number: 4725665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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
• Patient Age: 7 YR