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

Catalog Number IAB-06840-U

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that a leak was found in the catheter and inflation was not happening while connecting with machine.Another catheter was used in the same insertion site to complete the procedure.No patient injury or consequence reported.The patient's current condition is reported as "discharged".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The reported complaint for iab "catheter found leak and inflation was not happening while connecting with machine" 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 for reports of this nature.

Event Description

It was reported that a leak was found in the catheter and inflation was not happening while connecting with machine.Another catheter was used in the same insertion site to complete the procedure.No patient injury or consequence reported.The patient's current condition is reported as "discharged".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18820485
• MDR Text Key: 336754901
• Report Number: 3010532612-2024-00146
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23K0060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• 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.