MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN915319

Device Problems Defective Device (2588); Reset Problem (3019); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

Patient arrived from cath lab with teleflex intra-aortic balloon pump (iabp).On examination noted that the transducer was not zeroed.Called the company rep - instructed on a manual zero of the transducer.Checked the fos port- it is nonfunctional and defective.Teleflex rep will deliver replacement balloon - wants the defect balloon when it is removed for examination.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13009729
• MDR Text Key: 282272665
• Report Number: 13009729
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021,11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/30/2021
• Date Report to Manufacturer: 12/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male