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

Catalog Number IAB-06830-U

Device Problem Crack (1135)

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that "icu staff discovered bleeding, luer lock of the item broken, causing disconnection of the device".The issue was resolved by changing to another extension pressure tubing set.The iab was not removed.No patient harm or injury, and no blood loss as the defect was found immediately.The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The reported complaint that the "luer lock of the item broken" was confirmed based on the customer photo provided with the complaint report.The damage consisted of the male luer end being broken and separated from the arterial pressure (ap) tubing.The issue reviewed in the photo is consistent with the reported complaint.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 broken luer of the ap tubing.The root cause of the complaint was undetermined.A potential cause was user handling, where the ap connection was overtightened.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "icu staff discovered bleeding, luer lock of the item broken, causing disconnection of the device".The issue was resolved by changing to another extension pressure tubing set.The iab was not removed.No patient harm or injury, and no blood loss as the defect was found immediately.The patient status is reported as "fine".

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17851428
• MDR Text Key: 324688317
• Report Number: 3010532612-2023-00553
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23D0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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
• Patient Age: 64 YR
• Patient Weight: 51 KG