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

Catalog Number	IAB-S730C
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 10 minutes, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Remove the catheter and change the new one".No patient injury or consequence reported.The patient's current condition is reported as "fine".
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.
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 10 minutes, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Remove the catheter and change the new one".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 10 minutes, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Remove the catheter and change the new one".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton/sealed ziploc bag.Upon return, the super arrow-flex (saf) sheath was noted on the iabc.The one-way valve was noted tethered to the short driveline tubing.The supplied data-scope inflation driveline tubing was connected to the short driveline tub-ing; no blood was noted within the returned inflation driveline tubing.The iabc bladder was fully un-wrapped.A kink to the iabc central lumen was noted at approximately 44.4cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.The sample was likely cleaned prior to the return.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0070in and was within specifica-tion 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 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 manufactur-ing procedure.A leak was immediately detected from the bladder membrane.Under microscopic inspection, a leak sites consistent with contact from a sharp object was noted at approximately 11.8cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 44.4cm from the iabc distal tip, 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.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 "gas was withdrawn from the helium pipeline and blood was found" is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iabc bladder, which can allow blood to enter the helium pathway.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifi-cations were not met during the complaint investigation due to the bladder leak.The probable root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22579424
• Report Number: 3010532612-2025-00679
• Device Sequence Number: 20603588
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)241025(17)260930(10)18F24K0105(21)
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 09/30/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24K0105
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 11/07/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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.; N/A.
• Patient Sex: Unknown