MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  Injury  

Event Description

Patient was in cath lab undergoing diagnostic cardiac catherization.The balloon pump was inserted in the right femoral artery for possible urgent cabg (coronary artery bypass graft).The balloon pump became dislodged in the femoral artery.Patient was taken to or.The leg appeared ischemic.Surgeon decided to remove iabp by cutting down the right groin and remove the iabp under direct vision, the cfa (common femoral artery) was repaired with 6-0 prolene stitches.Surgeon proceeded with planned cabg.Surgeon stated that situation was emergent but resulted in no permanent harm.Biomed is unable to verify which of the three balloon pumps was involved.Please see the information below, all three balloon pumps are the same manufacturer and model number.Manufacturer: datascope, model# 0998-00-3023-53(cs300).Manufacturer: datascope, model# 0998-00-3023-53(cs300).Manufacturer: datascope, model# 0998-00-3023-53(cs300).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 12432460
• MDR Text Key: 270155703
• Report Number: 12432460
• Device Sequence Number: 1
• Product Code: DSP
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2021
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28470 DA