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

Model Number 59353121

Device Problem Air Leak (1008)

Patient Problems Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Bayer service performed a check of the injector (sn (b)(4)) and the injector performed to specification.A bayer 150-ft-q syringe was used for the procedure, lot number unknown, and was discarded by the site.A third party high pressure connecting tubing (hpct) was used to connect the syringe to the injector, lot number unknown and also discarded by the site.A bayer clinical applications specialist provided retraining to the site on 12/05/2017.

Event Description

The site reported the following: a (b)(6) year old male outpatient with a diagnosis of double outlet right ventricle (dorv) and a ventricular septal defect (vsd) was having a diagnostic right heart catheterization performed while connected to a bayer medrad provis injector.The patient was intubated and under general anesthesia for this procedure.Toward the end of a contrast injection an undisclosed amount of air was accidentally injected into the aortic root.When the air bubbles were visualized, the injector tubing was immediately disconnected from the catheter.The patient became hypotensive and anesthesia staff treated him with an epinephrine drip, and 100% oxygen.The patient immediately responded to this treatment, stabilized and remained stable.A transesophageal echocardiogram (tee) was performed and troponin levels were checked, both results were negative.The patient was admitted to the hospital overnight and a neurological consult was ordered.The neurologist found no deficits and the patient was discharged the next morning.

• Brand Name: MARK V PROVIS
• Type of Device: ANGIOGRAPHIC INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: linda mcdonald ; one bayer drive; indianola, PA 15051 ; 7249407412
• MDR Report Key: 7117677
• MDR Text Key: 94855564
• Report Number: 2520313-2017-00080
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59353121
• Device Catalogue Number: PROVIS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2011
• 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; Required Intervention
• Patient Age: 41 YR