MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN917285

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

Registered nurse (rn) assessed intra-aortic balloon pump (iabp).Fiber-optics not transducing or producing wave on console.Rn assessed black flecks in drive line.Physician's assistant (pa) called to bedside.Pa immediately disconnected iabp catheter as indicated.Upon removal, iabp catheter was tortuous and twisted with a large hole present.No balloon pump alarms went off to detect a helium loss.No apparent harm to patient.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 16271702
• MDR Text Key: 308467807
• Report Number: 16271702
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: (01)10801902172065
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: GS20791
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Male
• Patient Weight: 61 KG