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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
Catalog Number IAB-S840C
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2023
Event Type  malfunction  
Event Description
It was reported that "a few hours after the catheter is inserted, the machine sounds an alarm.The device was found to be leaking blood and was removed." as a result, 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).
 
Event Description
It was reported that "a few hours after the catheter is inserted, the machine sounds an alarm.The device was found to be leaking blood and was removed." as a result, 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).The serial number ((b)(6)) reported on the complaint report does not match the serial number on the returned sample.The serial number of the returned sample is (b)(6).The lot number of the returned sample is 18f23c0043.Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was a 60cc syringe; no damage or abnormality was noted with the syringe.Upon return, the distal end of the saf sheath was at approximately 40.9cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.An ap tubing was connected to the iabc luer; clear fluid was noted within the ap tubing.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A kink to the central lumen was noted at approximately 40cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample, including the one-way valve.Blood was also noted within the iabc helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0069in-0.0072in and was within specification of process document.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times according to quality system document q-96 with similar results.Blood was noted within the one-way valve upon cleaning.The one-way valve was properly cleaned and tested again; the one-way valve 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 q-96.The catheter's central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested and a leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed from approximately 10.8cm to 12.2cm from the iabc distal tip.A full thickness abrasion to the bladder was confirmed at approximately 11.4cm and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.1cm and 39.6cm from the iabc distal tip.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 44.6cm from the iabc luer.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.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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 bladder leak.The root cause of the bladder leak is related to patient condition.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 Key17563564
MDR Text Key321691395
Report Number3010532612-2023-00466
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10801902161977
UDI-Public10801902161977
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAB-S840C
Device Lot Number18F23C0043
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received09/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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