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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S730C
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 02/14/2024
Event Type  malfunction  
Event Description
It was reported "the patient underwent aortic balloon counterpulsation catheter placement and developed an aortic balloon counterpulsation catheter that failed to pass the guidewire." the user changed to a new catheter.No patient harm or injury.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc).Returned with the sample was the supplied 30cc inflation driveline tubing and ap tubing (short extension tubing and 60" tubing); all components were visually inspected, and no abnormalities were noted.Upon return, the peel away sheath was noted on the iabc.The one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen was noted kinked/damaged, consistent with flattened surfaces at approximately from 5.8cm to 53.7cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.No other damage or abnormalities were noted 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 and then 30 seconds five separate times.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris was noted.The iabc was leak tested and 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 approximately 51.9cm from the iabc distal tip, which was consistent with the previously noted kinks/flattened central lumen.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 31cm from the iabc luer, which was consistent with the previously noted kinks/flattened central lumen.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 for an "aortic balloon counter pulsation catheter that failed to pass the guidewire" is confirmed.Upon return, the iabc central lumen was noted damaged and was consistent with a flattened appearance.Resistance was noted upon loading a guidewire into the iabc central lumen.No other damage was noted to the central lumen.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/flattened central lumen.The root cause of the complaint is undetermined.A most probable potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.
 
Event Description
It was reported "the patient underwent aortic balloon counterpulsation catheter placement and developed an aortic balloon counterpulsation catheter that failed to pass the guidewire." the user changed to a new catheter.No patient harm or injury.The patient's current condition is reported as "fine".
 
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Brand Name
ARROW REDIGUARD IAB: 7FR 30CC
Type of Device
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19216450
MDR Text Key341468031
Report Number3010532612-2024-00286
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2024
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 Catalogue NumberIAB-S730C
Device Lot Number18F23L0033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received04/29/2024
Supplement Dates FDA Received05/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
Patient Age72 YR
Patient SexFemale
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