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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN038077
Device Problem Fluid/Blood Leak (1250)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/31/2023
Event Type  Injury  
Event Description
It was reported that blood was noted in the driveline tubing, the iab ruptured.As a result, the iab was surgically removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that blood was noted in the driveline tubing, the iab ruptured.As a result, the iab was surgically removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the bladder was noted fully unwrapped.A teflon sheath was noted on the returned iabc; the teflon sheath body/extrusion was noted cut near the teflon sheath hub and the remaining length of the teflon sheath body/extrusion was not returned with the sample.The distal end of the cut sheath was noted at approximately 32cm from the iabc distal tip; the teflon sheath hub appeared typical.Kinks were noted to the central lumen at approximately 30cm and 76.2cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.A small amount of dried blood was noted within the helium pathway.A dried orange media was noted on the exterior surfaces of the returned sample.The one-way valve and one-way valve tether were not returned with the sample.The one-way valve was not returned with the sample; therefore, it could not be tested.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.The iabc was leak tested and a small leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end is consistent with a crossover site between the central lumen and helium pathway.Upon further inspection, the crossover leak site was confirmed at the kink/damaged central lumen at approximately 76.2cm from the iabc distal tip.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 30.1cm and 76.1cm from the iabc distal tip, which are the locations of the previously noted kinks.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 8.7cm and 54.8cm from the iabc luer, which are 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 of iab blood in helium pathway is confirmed.During the investigation, a crossover leak was confirmed between the central lumen and helium pathway, which can cause blood to enter the helium pathway.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 crossover leak.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
 
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Brand Name
REDIGUARD IAB: 8FR 40CC
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 Key16829758
MDR Text Key314154398
Report Number3010532612-2023-00224
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902136732
UDI-Public00801902136732
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN038077
Device Catalogue NumberIAB-S840C
Device Lot Number18F22M0012
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient Weight72 KG
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