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

Catalog Number	H787CT75STSA0
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this reported event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by distributor in (b)(6), hospital has a surgeon who is having issues with the smart port.After being implanted the right side placement catheters tend to curve.The curve created sometimes causes the tip to rest against the wall of the ivc, affecting aspiration.In this one case, the physician opted to have the port/catheter removed and replaced.The patient's condition is reported as "stable." the used device has been discarded.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h787ct75stsa0) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5254793, 5272511 and 5254792).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.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 malposition." no adverse trend was indicated.The initial mdr report was sent based on information that the port was removed due to the tubing issue (malpositioned).Subsequent information from the end user revealed that port was not removed, the catheter tubing was just re-positioned.Angiodynamics has since deemed this to have been a non-reportable event.Angiodynamics medical affairs staff were consulted regarding this complaint event.They were also forwarded x-ray images for review.No definitive root cause could be determined.Medical affairs created a list of additional questions/images for the hospital which was forwarded to them through the distributor (in australia).There has been no response from the hospital.(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: 7624535
• Report Number: 1317056-2018-00118
• Device Sequence Number: 13798857
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Catalogue Number: H787CT75STSA0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1