MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARRPW ULTRA 8 IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S850C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump was alarming for "catheter alarms" after the patient returned from the or.The patient is critical, ventilated, has atrial fibrillation with episodes of v-tach on dobutamine and epinephrine at high doses.The user was unable to aspirate from the central lumen.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.
Additional Manufacturer Narrative
B)(4).
Event or Problem Description
It was reported that the pump was alarming for "catheter alarms" after the patient returned from the or.The patient is critical, ventilated, has atrial fibrillation with episodes of v-tach on dobutamine and epinephrine at high doses.The user was unable to aspirate from the central lumen.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4) the reported complaint that "the user was unable to aspirate from the central lumen" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.Other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #: udi related data quality updates only.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that the pump was alarming for "catheter alarms" after the patient returned from the or.The patient is critical, ventilated, has atrial fibrillation with episodes of v-tach on dobutamine and epinephrine at high doses.The user was unable to aspirate from the central lumen.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.

• Brand Name: ARRPW ULTRA 8 IAB: 8FR 50CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18372706
• Report Number: 3010532612-2023-00728
• Device Sequence Number: 12704453
• Product Code: DSP
• UDI-Device Identifier: 10801902144208
• UDI-Public: (01)10801902144208(11)230703(17)250630(10)18F23G0001(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: IAB-S850C
• Device Lot Number: 18F23G0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/23/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male