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 01/18/2024

Event Type  malfunction  

Event Description

I would have stated the following.It was reported "ruptured teleflex catheter"."patient needed mcs support".It was reported that "when blood was seen in [the] helium drive-line", it was decided to remove the catheter.Another iab was inserted within the same insertion site.Additionally, it was noted that patient was using a maquet transport pump when transferring between medical centers then transferred back to a teleflex pump.No patient injury or consequence reported.Patients condition was reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

I would have stated the following.It was reported "ruptured teleflex catheter"."patient needed mcs support".It was reported that "when blood was seen in [the] helium drive-line", it was decided to remove the catheter.Another iab was inserted within the same insertion site.Additionally, it was noted that patient was using a maquet transport pump when transferring between medical centers then transferred back to a teleflex pump.No patient injury or consequence reported.Patients condition was reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint for iab blood in helium pathway 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: 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: 18681600
• MDR Text Key: 335048132
• Report Number: 3010532612-2024-00099
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23J0035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• 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: MARQUET PUMP; MARQUET PUMP