MAUDE Adverse Event Report: TELEFLEX INCORPORATED FIBEROPTIX IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN915319

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2021

Event Type  malfunction  

Event Description

Arrow iabp inserted during cath lab procedure.Post procedure, poor augmentation, poor arterial waveform being transduced, no fibro optics.Blood noted in the helium balloon line.

• Brand Name: FIBEROPTIX IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11526567
• MDR Text Key: 241005827
• Report Number: 11526567
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN915319
• Device Catalogue Number: IAB-05840-LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Date Report to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA