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

Catalog Number IAB-06840-U

Device Problem Difficult to Remove (1528)

Patient Problem Great Vessel Perforation (2152)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The report states, "placed pre-op cabg on (b)(6) 2023, or 10/25, ccl (b)(6) for pci (aborted due to vascular injury after balloon pump removal).Removal of iab attempted before pci, encountered difficulties attempts to completely deflate iab for removal unsuccessful resulting in femoral artery dissection, treated with 2 viabahn stents.After procedure patient transferred to cticu @ 1830.Patient became abruptly hypotensive approximately 9 pm with rapid decline, cardiac arrest and subsequent expiration despite rescue efforts".In additional information received, the customer states "based on the findings from our own review we are withdrawing our concern regarding the teleflex iab.I am unable to furnish you with any additional information".

Event Description

The report states, "placed pre-op cabg on (b)(6) 2023, or (b)(6) 2023, ccl (b)(6) 2023 for pci (aborted due to vascular injury after balloon pump removal).Removal of iab attempted before pci, encountered difficulties attempts to completely deflate iab for removal unsuccessful resulting in femoral artery dissection, treated with 2 viabahn stents.After procedure patient transferred to cticu @ 1830.Patient became abruptly hypotensive approximately 9 pm with rapid decline, cardiac arrest and subsequent expiration despite rescue efforts".In additional information received, the customer states "based on the findings from our own review we are withdrawing our concern regarding the teleflex iab.I am unable to furnish you with any additional information".

Manufacturer Narrative

Qn# (b)(4).The reported complaint for balloon would not deflate completely 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 is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• 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: 18132863
• MDR Text Key: 328069917
• Report Number: 3010532612-2023-00640
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23G0063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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