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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000262
Device Problem Unraveled Material (1664)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was used on a patient.It was noted by the staff that the balloon was found dispersed after opening the package which caused it to not be able to pass through the femoral artery sheath into the patient.As a result, a new iab was used to complete the treatment.There was a report of patient death, doctor wenzhai cao judged that the device did not cause or contributes to the patient's death.
 
Manufacturer Narrative
(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of balloon dispersed after opening is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that the intra-aortic balloon (iab) was used on a patient.It was noted by the staff that the balloon was found dispersed after opening the package which caused it to not be able to pass through the femoral artery sheath into the patient.As a result, a new iab was used to complete the treatment.There was a report of patient death, doctor wenzhai cao judged that the device did not cause or contributes to the patient's death.
 
Manufacturer Narrative
Qn# (b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f20c0044) reported on the complaint report does not match the lot number for the returned sample.The lot number for the returned sample is 18f20a0026.Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was loosely packed in a biohazard bag.The iabc was returned twisted upon itself.The peel away sheath was noted on the returned iabc.The one-way valve was tethered and connected to the short driveline tubing.A dried substance was noted in the short driveline tubing.The iabc bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 19.3cm from the iabc distal tip.No blood was noted on any exterior or interior surfaces.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.It was noted that there was no seal inside the one-way valve and the one-way valve was able to be easily taken apart by hand.The one-way valve seal was found in the short driveline tubing.The one-way valve seal was reinserted 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.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.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 19.3cm from the iabc distal tip, which is the location of the previously noted bend.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 65.6cm from the iabc luer, which is the location of the previously noted bend.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 the balloon unwrapping prematurely is confirmed.The returned one-way valve failed the functional testing.The 2 pieces of the one-way valve housing were found to be loosely connected, which allowed the seal to move freely and end up in the short driveline tubing.This would cause the balloon to unwrap immediately after removing the negative pressure from the syringe.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 failed one-way valve test.The root cause of this complaint is manufacturing related.
 
Event Description
It was reported that the intra-aortic balloon (iab) was used on a patient.It was noted by the staff that the balloon was found dispersed after opening the package which caused it to not be able to pass through the femoral artery sheath into the patient.As a result, a new iab was used to complete the treatment.There was a report of patient death, doctor (b)(6) judged that the device did not cause or contributes to the patient's death.
 
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Brand Name
REDIGUARD IAB: 7FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville, MA 27560
MDR Report Key11329836
MDR Text Key232327381
Report Number3010532612-2021-00030
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002686
UDI-Public00801902002686
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,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20A0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2020
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 Age65 YR
Patient SexMale
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