MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD BASIXCOMPAK ANALOG INFLATION DEVICE

Catalog Number K1550403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bradycardia (1751); Death (1802)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

Event Description

The account alleges that during a percutaneous transluminal coronary angioplasty [ptca] procedure via a contrast auto injection system, air was introduced into the patient's coronary artery.The physician had acquired retrograde arterial access and had negotiated a guide catheter through the ascending aorta to cannulate the vascular ostium and opacify the targeted coronary artery.During the procedure contrast was removed from the contrast auto injectors stopcock to prep the inflation device for intervention.The physician states that the contrast auto injector that was attached to a hemostasis device and a guide catheter was visually cleared of any air within the line before continuing with the necessary selective angiograms.A few seconds later the patient's ecg indicated bradycardia and the patient was complaining of pain within the thoracic region of their body.The physician states that air bubbles were identified within the injection line.The contrast power injector did not detect any air within the line before injections.The inflation device and hemostasis valve were used to finish the interventional procedure for the patient.The patient expired two weeks later due to circumstance unknown to the medical device manufacturer.

• Brand Name: BASIXCOMPAK ANALOG INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8772867
• MDR Text Key: 156137975
• Report Number: 9616662-2019-00007
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: K1550403
• Device Lot Number: IN4330/F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention