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

Catalog Number	H787CT66LTPD0
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
As reported by angiodynamics' distributor in (b)(6), 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.
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 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 performation 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
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8311662
• Report Number: 1317056-2019-00033
• Device Sequence Number: 16632824
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 09/30/2020
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 5238634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/28/2019
• 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