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

Catalog Number IAB-06830-U

Device Problem Inflation Problem (1310)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported " after inserting the balloon into the patient and starting the pump it was found that the upper part of the balloon did not inflate".To continue therapy, another iab catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided photos and a video for evaluation.The photos show the iabc bladder under fluoroscopy and the bladder was not fully inflating/would not fully unwrap.The video shows the iabc bladder under fluoroscopy and the bladder was not fully inflating/would not fully unwrap near the iabc distal tip during pumping.The photos and video are consistent with the reported complaint.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "upper part of the balloon did not inflate" is confirmed based on the customer photos and video provided by the customer.In the photos and video, the iabc bladder was noted not fully inflating/would not fully unwrap near the iabc distal tip.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder not fully inflating/unwrap.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 " after inserting the balloon into the pateint and starting the pump it was found that the upper part of the balloon did not inflate".To continue therapy, another iab catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is 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: 19216625
• MDR Text Key: 341468003
• Report Number: 3010532612-2024-00270
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23J0011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Female