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

Catalog Number SRB24AC

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Date 03/27/2019

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-diagnostic angiogram, a radial hemostasis band was successfully placed.The nurse states that after 5 min within the post procedure recovery unit, the patient acquired a hematoma.The hematoma was treated with manual compression and the placement of a second radial compression band a little more proximal to first.The patient's condition worsened and a pseudoaneurysm was later identified.The patient underwent surgical repair for the pseudoaneurysm.

• 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: 8531372
• MDR Text Key: 142483861
• Report Number: 1721504-2019-00028
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SRB24AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70