MAUDE Adverse Event Report: GENTINGE USA SALLES, LLC. CATH,LINEAR 7.5FR IABP WI/KIT40CC; IABP KIT

Lot Number 300278140

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2023

Event Type  Injury  

Event Description

The patient presented with anterior stemi and had multiple bouts of ventricular arrhythmias prior to arrival.Lad was occluded and an intra-aortic balloon pump was required for hemodynamic stability.Access to place the iabp was gained in the left femoral artery using ultrasound guidance and micropuncture tools.A 0.035¿ j-tip guidewire was then introduced, and a 7.5 french armored maquet sheath was introduced.As the dilator and wire were being removed, the dilator hub sheared at the site of the sheath diaphragm, leaving a fragment of the dilator in the patient.Attempts were made to remove the dilator, but these were unsuccessful.The patient had to go emergently to the operating room to have the retained portion of the dilator removed by an open vascular surgery.

• Brand Name: CATH,LINEAR 7.5FR IABP WI/KIT40CC
• Type of Device: IABP KIT
• Manufacturer (Section D): GENTINGE USA SALLES, LLC.; 45 barbour pond drive; wayne NJ
• MDR Report Key: 16673140
• MDR Text Key: 312649746
• Report Number: 16673140
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 300278140
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2023
• Distributor Facility Aware Date: 03/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American