MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Leak/Splash (1354)

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

Event Date 03/09/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "micro leak in balloon membrane leading to unable filling od helium".To continue therapy the catheter was removed and replaced in the same insertion site.No patient harm or injury reported.The patient's current condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The reported complaint for "micro leak in balloon membrane" 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.

Event Description

It was reported "micro leak in balloon membrane leading to unable filling od helium".To continue therapy the catheter was removed and replaced in the same insertion site.No patient harm or injury reported.The patient's current condition reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19075922
• MDR Text Key: 339893490
• Report Number: 3010532612-2024-00260
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23M0053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1