MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	H749651911571
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	ST Segment Elevation (2059)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the used y-adaptor will be returned for evaluation, but it has not yet arrived.Upon receipt of the device sample and conclusion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by hospital, patient was brought to the redial cath lab on (b)(6) 2018 for a coronary angiogram which turned into a percutaneous coronary intervention.The leak in the y-adaptor caused an air injection into the coronary vessels resulting in an st-elevation with hemodynamic changes.There was no delay of care, care was immediate, no additional injury or medical treatment was needed.The patient was seen on (b)(6) 2018 for a follow-up and was doing fine.The used y-adaptor will be returned to angiodynamics for evaluation.
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 recent angiodynamics complaint report was reviewed for the y-adaptor product family and the failure mode "air bubbles."no adverse trend was identified.This is the only reported complaint for this failure mode in the past 15 months for the y-adaptor product family and, as such, may be considered an isolated incident.The reported complaint description is deemed confirmed and is a result of a missing component (gland/washer).The most likely root cause for this type of failure is that responsible employees failed to follow proper procedures as outlined in the assembly instructions for the y-adaptor.A department-wide awareness for manufacturing associates who work in the manual assembly area has been performed on the applicable procedures.Although the operators involved in assembling the device from the reported lot are no longer employed by angiodynamics, signed training record show that the employees were trained on the applicable procedures at the time the lots were manufactured.Manufacturing process controls for the y-adaptor include 100% visualization for damage, foreign matter, or missing components and in-process air leak testing.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7549068
• Report Number: 1317056-2018-00090
• Device Sequence Number: 13521825
• Product Code: OEZ
• UDI-Device Identifier: H749651911571
• UDI-Public: H749651911571
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: Physician
• Device Catalogue Number: H749651911571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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: 68 YR
• Patient Weight: 91