MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S730C
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "this patient had a normal puncture, the catheter was opened and vacuumed, the catheter was removed flat, a loose balloon could not be implanted, the doctor vacuumed again, it is still loose, the catheter could not be completely wrapped and could not into the sheath, and so the doctor withdraw the catheter there was a small localized hematoma at the insertion site; the patient condition is fine.Other treatment will be taken." a 2nd catheter was not inserted.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The reported complaint of iab unwrapped prematurely is confirmed.The iabc bladder was fully unwrapped upon receipt of the sample.The customer returned a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with an original packaging box that does not match the serial number on the returned sample (inp-2, inp-4) for investigation.The sample was returned in a brown cardboard box and was loosely packed within the packaging carton (inp-1, inp-5).Upon return, the one-way valve was tethered to the short driveline tubing (inp-7).The bladder was fully unwrapped (inp-8).A kink was noted to the central lumen at approximately 20.2cm from the iabc distal tip (inp-9).Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.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 iabc 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.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 iab distal tip.The guidewire met resistance at approximately 18.6cm and the guidewire could not advance at approximately 20.2cm from the iab distal tip.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance at approximately 14.2cm and the guidewire could not advance at approximately 65.1cm from the iab luer.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 unwrapped bladder.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.
Event or Problem Description
It was reported that "this patient had a normal puncture, the catheter was opened and vacuumed, the catheter was removed flat, a loose balloon could not be implanted, the doctor vacuumed again, it is still loose, the catheter could not be completely wrapped and could not into the sheath, and so the doctor withdraw the catheter there was a small localized hematoma at the insertion site; the patient condition is fine.Other treatment will be taken." a 2nd catheter was not inserted.No patient harm or injury.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• 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: 17408220
• Report Number: 3010532612-2023-00426
• Device Sequence Number: 7122076
• Product Code: DSP
• UDI-Device Identifier: 10801902161960
• UDI-Public: 10801902161960
• 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
• Report Date (Section B): 07/11/2023

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: 06/30/2024
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F22G0050
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown