MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038077
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "highly torturous femoral artery, the sheath and the shaft of iabp was kinked and the balloon was not inflating, balloon was removed as bp was not displayed".Additional information states that a 2nd iab was used and inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional 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.
Event or Problem Description
It was reported that, "highly torturous femoral artery, the sheath and the shaft of iabp was kinked and the balloon was not inflating, balloon was removed as bp was not displayed".Additional information states that a 2nd iab was used and inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The lot number reported is 18f22j0014.Returned for investigation was a 40cc 8fr rediguard in-tra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed ziploc bag.Upon return, the peel away sheath extrusion was noted cut.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.More than 15 kinks to the iabc central lumen were noted throughout the length of the iabc.No blood was noted on the interior or the exterior surfaces of the returned sample.The sample was likely cleaned prior to its return.No other visual damage or abnormalities were not-ed to the returned sample.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute according to quality system document.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory s yringe.No abnormali-ties or debris were noted.The iabc was leak tested using in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "shaft of iabp was kinked" is confirmed.The intra-aortic balloon catheter (iabc) was returned with multiple kinks to the central lumen.The iabc bladder was fully intact with no damage noted.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 kinked central lumen.The root cause of the kinked central lumen is undetermined; a potential root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "highly torturous femoral artery, the sheath and the shaft of iabp was kinked and the balloon was not inflating, balloon was removed as bp was not displayed".Additional information states that a 2nd iab was used and inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Common Device Name: 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16467192
• Report Number: 3010532612-2023-00130
• Device Sequence Number: 7482263
• Product Code: DSP
• UDI-Device Identifier: 10801902172942
• UDI-Public: (01)10801902172942(11)220913(17)240831(10)18F22J0014(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: IPN038077
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22J0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 02/05/2026
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/12/2023; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female