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

Catalog Number IAB-06850-U

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "balloon rupture".Additional information states " two catheters were used on this patient, one from getinge and one from arrow.Not sure which was used first,but both had ruptures".Patient complications or injury unknown.Patient current condition unknown.At the time of this report, the customer has not returned our requests for additional information.

Event Description

It was reported "balloon rupture".Additional information states " two catheters were used on this patient, one from getinge and one from arrow.Not sure which was used first,but both had ruptures".Patient complications or injury unknown.Patient current condition 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 for iab "balloon rupture" was not able to be confirmed as 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.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18750549
• MDR Text Key: 335894685
• Report Number: 3010532612-2024-00124
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23L0045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• 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.