MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 4FR FOGARTY BALLOON CATHETERS; CATHETER, EMBOLECTOMY

Lot Number 63412917

Device Problem Inflation Problem (1310)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/17/2022

Event Type  Injury  

Event Description

During a left thigh exploration for ballistic wound trauma.At least 4 different 4fr fogarty balloon catheters were opened to the sterile field to help control bleeding, and none of the balloons would inflate.Event abated after use stopped or dose reduced? yes; event reappeared after reintroduction? no.Diagnosis for use: bleeding.

• Brand Name: 4FR FOGARTY BALLOON CATHETERS
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 15085646
• MDR Text Key: 296468254
• Report Number: MW5111051
• Device Sequence Number: 4
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/20/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Lot Number: 63412917
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic
• Patient Race: White