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

Catalog Number H787CT66LTPD0

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Angiodynamics is attempting to obtain additional (translated) information regarding the event including the date of the event, additional event details / if any intervention was required, and patient condition.Upon completion of the investigation a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported by angiodynamics' distributor in (b)(4), during an attempted implantation of a smart port, a vessel was punctured due to a "rigid guidewire and introducer." the port was not implanted.In the post-operative period, a chest ct was performed to assess the patient's condition.Angiodynamics is attempting to obtain additional (translated) information regarding this event as well as the patient condition.

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 february 2019 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "patient injury." no adverse trend was indicated.In addition, the events at this end user facility are the only reported occurrences for guidewire vessel preformation for the smartport product family in the past 15 months, as such, these are deemed to be isolated incidents.The reported complaint description cannot be confirmed, as no sample was returned, nor can exact root cause be determined.Potential contributing factor to patient injury may have been excessive guidewire manipulation during vessel access.As indicated by angiodynamics' distributor in poland, the end user facility was a former bard port user.The distributor won the tender to supply ports to facility and these were the first 3 units shipped to them.The end user facility is back using bard ports.Since the end user has not cooperated in providing information/samples, the reported events may be user preference regarding brand of port used rather than malfunctioning smartport device/accessories.((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: 8311660
• MDR Text Key: 135210213
• Report Number: 1317056-2019-00031
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (y/n): N
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 5238634
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention