MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDESYNC¿.RADIAL COMPRESSION DEVICE

Catalog Number SRB24MED

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

Patient Problem Air Embolism (1697)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that post radial access procedure within the cath lab, a hemostasis band was in position on the patient's arm, ready for deployment, when a staff member dropped the hemostasis band's designated inflation syringe onto the floor.A compatible competitor's syringe was placed on the sterile field by a member of the staff that could be used for successful deployment of the hemostasis band.The physician picked up the syringe and injected 20cc's of air into the side arm of the vascular access sheath instead of the hemostasis band's side arm.Patient harm was caused due to air being accidentally injected into the radial artery.The patient was noted to be doing better at time of transfer to a sister medical center for hyperbaric chamber treatment.

• Brand Name: PRELUDESYNC¿.RADIAL COMPRESSION DEVICE
• Type of Device: RADIAL COMPRESSION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8722847
• MDR Text Key: 148791352
• Report Number: 1721504-2019-00044
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SRB24MED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BD SYRINGE
• Patient Outcome(s): Hospitalization; Required Intervention