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

Catalog Number H787CT80STPD0

Device Problem Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Although it has been indicated that the used device will be returned to angiodynamics for evaluation, it has not yet arrived.Upon completion of the investigation a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported smartport which had been placed on (b)(6) 2018 was removed and replaced on (b)(6) 2018 due to "occlusion." no patient complications were reported.The used device is expected to be returned to angiodynamics for evaluation.

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 smartport product family and the failure mode "catheter fractured." no adverse trend was identified.The used device was returned with the catheter tubing attached to the port at the 15cm mark; the distal tip end of the catheter tubing was at 0cm mark.The catheter tubing was fractured between the 10cm and 11cm marks.As reviewed, the septum had multiple puncture marks.The printing (depth marks) on the catheter was very worn 4 to 6 cm from the port.There were 4 longitudinal cracks in the catheter 5 cm from the port.The catheter was highly discolored at the severed spot.When tested, the port passed the occlusion test but failed leak testing due to the multiple cracks, as noted.The catheter was measured, and the id and od were found to be within specification.Although no definite root cause could be identified for the damage, the cracks (approx.5 cm from the port) on the catheter and worn printing suggest it was possibly pinched likely due to "pinch-off syndrome." most likely this was the cause of the cracks.The rest of the catheter was found to be normal in appearance and measured within specification.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
• Type of Device: PORT & CATHETER IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7475092
• MDR Text Key: 106978132
• Report Number: 1317056-2018-00053
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: 5143722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR