MAUDE Adverse Event Report:; CLAMP, VASCULAR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Patient status post diagnostic left heart catheterization.Angioplasty specialist placed tr band to right radial artery to achieve hemostasis.However, despite adding increasing amounts of air (15 cc), patient continued to bleed.Vasc band applied, with resolution of bleeding.However, patient with hematoma in holding area, that required manual compression and ace wrap x 3 hours.Upon discharge time, vasc band and ace wrap removed without bleeding or hematoma, + radial pulse.Reported discussed application with experienced angioplasty specialist, and she denies difficult access or anatomy.Raised concern for integrity of tr band.

• Type of Device: CLAMP, VASCULAR
• MDR Report Key: 14547024
• MDR Text Key: 292996310
• Report Number: 14547024
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2022,11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female