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

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "a large amount of blood return was found, which was detected and promptly withdrawn the catheter, and it was found to be caused by a central lumen fracture in the front of the balloon.No patient injury resulted due to timely management and replacement of the second set of catheter." the 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint of iab blood in the helium pathway is 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 was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "a large amount of blood return was found, which was detected and promptly withdrawn the catheter, and it was found to be caused by a central lumen fracture in the front of the balloon.No patient injury resulted due to timely management and replacement of the second set of catheter." the 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: 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: 18095220
• MDR Text Key: 327667055
• Report Number: 3010532612-2023-00630
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 18F23G0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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: 43 YR
• Patient Sex: Male