MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 8FR 50CC; System, balloon, intra-aortic and control

Model Number IPN038264

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

Complaint received via medwatch report# (b)(4).It was reported that "teleflex iabp- model iab-06850-u, redacted.Device became disconnected at sterile sheath and removed from sheath site approx.8 inches at 1155 and ultimately device had to be removed from patient.Patient was repositioning independently in bed during time of displacement.Iabp removed at bedside by attending".Further information states that there was not an attempt at placing at a second catheter.Medical intervention was not provided as patient ultimately expired per family goals of care.Additional information states, death occurred (b)(6) 2022.No cause of death reported.

Manufacturer Narrative

(b)(4).

Event Description

Complaint received via medwatch report# 2600320000-2022-8202.It was reported that "teleflex iabp- model iab-06850-u, serial # redacted.Device became disconnected at sterile sheath and removed from sheath site approx.8 inches at 1155 and ultimately device had to be removed from patient.Patient was repositioning independently in bed during time of displacement.Iabp removed at bedside by attending".Further information states that there was not an attempt at placing at a second catheter.Medical intervention was not provided as patient ultimately expired per family goals of care.Additional information states, death occurred 09 nov 2022.No cause of death reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ULTRAFLEX IAB: 8FR 50CC
• Type of Device: System, balloon, intra-aortic and control
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15940118
• MDR Text Key: 305078403
• Report Number: 3010532612-2022-00552
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: 10801902144192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN038264
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F22J0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 61 KG