MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS

Catalog Number	H965251860
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h965251860) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The shr indicated the reporting customer only received {one lot} of this item number in the six months prior to the procedure.The {one} lot obtained through the shr was (5211847).The device history records for the los obtained through the ship history report (packaging lot) was reviewed.In addition, the corresponding lots for purchased component item number 10800060 (angiodynamics lots {628133, 631329 and 631795} packaged in it.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 angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.The used device was not returned to angiodynamics for evaluation, therefore a failure analysis is not available.We are unable to determine if the device met specification and the relationship, if any, between the device and the reported event.The clinical specialist (who is no longer available to contact) stated at the time of the procedure that the patient injury was not a result of device malfunction, but operator-related.((b)(4)).
Event or Problem Description
As reported during an angiovac procedure the physician damaged the femoral vein (vessel perforation) resulting in bleeding in the patient's stomach.Upon completion of the case, the cannula was removed, the blood returned to the patient via bolus flush and the sites were closed with light pressure held until hemostasis was achieved.The angiodynamics clinical specialist present during the case indicated that there was "no malfunction of the angiovac device.".

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Common Device Name: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8466010
• Report Number: 1317056-2019-00053
• Device Sequence Number: 1341141
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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 Catalogue Number: H965251860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/29/2019
• 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
• Patient Age: 34 YR