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

Model Number	IPN915328
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The report states "after the sheath was inserted, the catheter was evacuated, and when implanted, it could not pass through the central cavity of the catheter, and the catheter was found kinked.Successful implantation after replacement of a new catheter." additional information states that a secondary catheter was inserted at the same insertion site.No delay in therapy.No report of patient harm or injury.
Event or Problem Description
The report states "after the sheath was inserted, the catheter was evacuated, and when implanted, it could not pass through the central cavity of the catheter, and the catheter was found kinked.Successful implantation after replacement of a new catheter." additional information states that a secondary catheter was inserted at the same insertion site.No delay in therapy.No report of patient harm or injury.
Additional Manufacturer Narrative
Qn# (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.
Additional Manufacturer Narrative
(b)(4).The reported compliant of iab kinked was confirmed upon investigation of the returned sample.The customer returned a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in a cardboard box and was in a ziploc bag (inp-1, inp-2).Upon return, the one-way valve was tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped (inp-6).A kink to the iabc central lumen was noted at approximately 5.8cm from the iabc distal tip (inp-7).Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0067in-0.0078in and was within specification of process document.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 and then 30 seconds five separate times according to quality system document.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the bladder membrane (anp-1).Under microscopic inspection, the leak site is consistent with contact from a sharp object and was noted at approximately 16.2cm from the iabc distal tip (anp-2, anp-3).Based upon the reported complaint and visual inspection, the bladder leak site is consistent with contact from a sharp object and likely occurred after the device was removed from the patient.The customer did not report any issues related to a leak and no blood was noted within the helium pathway.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance at approximately 6.2cm from the iabc distal tip, which is the locations of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 78.5cm from the iabc luer, which is the location of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris was 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 kink was undetermined, but a most probable potential cause was customer handling.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.
Event or Problem Description
The report states "after the sheath was inserted, the catheter was evacuated, and when implanted, it could not pass through the central cavity of the catheter, and the catheter was found kinked.Successful implantation after replacement of a new catheter." additional information states that a secondary catheter was inserted at the same insertion site.No delay in therapy.No report of patient harm or injury.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15626901
• Report Number: 3010532612-2022-00424
• Device Sequence Number: 12307969
• Product Code: DSP
• UDI-Device Identifier: 20801902162001
• UDI-Public: 20801902162001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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 Expiration Date: 02/28/2024
• Device Model Number: IPN915328
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22C0007
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 03/17/2024
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/14/2022; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 77 KG