MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "iab catheter found manufacturing defect balloon.Balloon was leaking from joint area".To complete the procedure, the catheter was removed and replaced by the physician in the same insertion site.No patient injury or consequence reported.Patient's current condition reported as "unknown".At the time of this report, the customer has not returned our requests for additional information.

Event Description

It was reported "iab catheter found manufacturing defect balloon.Balloon was leaking from joint area".To complete the procedure, the catheter was removed and replaced by the physician in the same insertion site.No patient injury or consequence reported.Patient's current condition reported as "unknown".At the time of this report, the customer has not returned our requests for additional information.

Manufacturer Narrative

Qn# (b)(4).The reported complaint that the "balloon was leaking" is confirmed based on a video submitted by the customer.The video shows a leak from the proximal end of the iabc bladder.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 leaking bladder.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.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 40CC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18820357
• MDR Text Key: 336757756
• Report Number: 3010532612-2024-00150
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup
• Report Date: 02/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23G0028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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
• Treatment: N/A.; N/A.
• Patient Age: 64 YR
• Patient Sex: Female