MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MARK V PROVIS; ANGIOGRAPHIC INJECTOR

Model Number 59935996

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); No Code Available (3191)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

A bayer service representative performed an injector checkout of the mk v plus injector system.The system was found to perform to specification.There is no evidence of product malfunction.There were no disposables available for evaluation.In addition, lot numbers were not provided; therefore retained samples are not able to be tested.The customer declined an offer of additional applications training at this time.This information does not constitute an admission that the device, the company or its employees caused or contributed to this reportable event.

Event Description

A bayer representative reported the following: the customer reported that an alleged air injection occurred on a (b)(6) year old, male patient attached to the mk v plus injector system while undergoing a cardiac angiogram for cad (coronary artery disease).Following the injection of the contrast, the patient suffered cardiac arrest and was admitted to the intensive care unit.The patient was reported to have some residual swallowing and speech complications.The patient was transferred to the rehabilitation unit for recovery.Microbubbles of air were noted on the films post procedure during review the next morning.

• Brand Name: MARK V PROVIS
• Type of Device: ANGIOGRAPHIC INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: ms. sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 6934218
• MDR Text Key: 89155763
• Report Number: 2520313-2017-00064
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59935996
• Device Catalogue Number: MK V PLUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR