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

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Material Rupture (1546); Noise, Audible (3273)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Patient had grafted axillary intra-aortic balloon pump (iabp) in place.Patient was sitting in the chair eating breakfast when he noticed the iabp was making a strange noise.He alerted his nurse who assessed that the balloon had ruptured, and blood was backing up into the helium line.The nurse paused the iabp, clamped the line and emergently notified the team.Patient was emergently brought back to bed and all pertinent teams came to bedside.Cts surgeon was at bedside and attempted to remove iabp through sheath with difficulty.During this the sheath pulled out of graft and the graft retracted back into the body and was bleeding into the patient.The surgeon did manage to get to the artery and control bleed.Patient was brought emergently to cath lab for new femoral iabp placement.Original iabp was an 8 french with 50 ml balloon; axillary placement.Replaced with 8 french, 50 ml femoral location.

• Brand Name: IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9659330
• MDR Text Key: 177378434
• Report Number: 9659330
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6935 DA