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

Catalog Number IAB-06830-U

Device Problem Material Rupture (1546)

Patient Problem Thromboembolism (2654)

Event Date 01/13/2024

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "removing a ruptured balloon causes blood clots to travel elsewhere".The patient is reported as deceased.Additional information received states that the reported cause of death is "the blood clots travel to other places".The patient's past medical history includes "kidney dialysis patient".Their hospital course involves "cardiogenic shock, support by iabp since (b)(6) 2024, remove iab on (b)(6) 2024 due to iab rupture ihca during cag, s/p cpr 43 minutes with rosc.Cad with tvd s/p cabg on (b)(6) 2024".The blood clots were reported to travel to the "iliac heart renal artery".The date of death is (b)(6) 2024.

Manufacturer Narrative

(b)(4), the reported complaint of iab blood in helium pathway is confirmed.During the investigation, blood was confirmed within the iabc helium pathway and various damages were immediately noted to the iabc.The damages included a cut/torn bladder, bent/kinked central lumen and other bladder damage; also, a section of the bladder was not returned.Due to the combined damages and returned state of the device, it could not be confidently determined what initially caused the blood to enter the helium pathway.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 blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.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 "removing a ruptured balloon causes blood clots to travel elsewhere".The patient is reported as deceased.Additional information received states that the reported cause of death is "the blood clots travel to other places".The patient's past medical history includes "kidney dialysis patient".Their hospital course involves "cardiogenic shock, support by iabp since (b)(6) 2024, remove iab on (b)(6) 2024 due to iab rupture ihca during cag, s/p cpr 43 minutes with rosc.Cad with tvd s/p cabg on (b)(6) 2024".The blood clots were reported to travel to the "iliac heart renal artery".The date of death is (b)(6) 2024.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18953499
• MDR Text Key: 338275461
• Report Number: 3010532612-2024-00203
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23J0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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 Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male