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

Model Number	IPN915324
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the patient was admitted to the hospital on (b)(6) 2023, based on the diagnosis of 'acute inferior myocardial infarction'.On (b)(6) 2023, the stent operation was performed.After the doctor punctured the femoral artery for the patient, the doctor felt that the first intra-aortic balloon implantation was not smooth.After the aortic balloon implantation, the machine showed that it could not inflate.A new set was replaced and the operation was successful." there was no report of patient complications, serious injury or death.The 2nd iab was inserted at the same insertion site.The patient condition is reported as "fine".
Event or Problem Description
It was reported that "the patient was admitted to the hospital on (b)(6) 2023, based on the diagnosis of 'acute inferior myocardial infarction'.On (b)(6) 2023, the stent operation was performed.After the doctor punctured the femoral artery for the patient, the doctor felt that the first intra-aortic balloon implantation was not smooth.After the aortic balloon implantation, the machine showed that it could not inflate.A new set was replaced and the operation was successful." there was no report of patient complications, serious injury or death.The 2nd iab was inserted at the same insertion site.The patient condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f22g0050) recorded on the complaint report matches the lot number on the returned original packaging box/label and for the returned sample.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.Returned with the sample were supplied kit components including 30cc inflation driveline tubing and data-scope inflation driveline tubing; no damage or abnormalities were noted to the returned components.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.No bends or kinks were noted to the iabc central/outer lumen.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.Unrelated to the reported complaint, a hemostasis cuff, which connects to the distal side of the cath-guard was noted missing from the iabc.It cannot be confidently determined that the hemostasis cuff was not originally assembled on the returned iabc/cath-guard.Additionally, no sheath was noted on the iabc or returned with the sample.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0066in.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 were noted.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with the returned 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; 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.No resistance was noted; 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 would not inflate completely is not confirmed.The returned intra-aortic balloon catheter (iabc) bladder was fully intact with no damage noted.During functional testing, the iabc bladder inflated and deflated completely with no alarms noted.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Other remarks: n/a.Corrected data: n/a.

• Brand Name: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16410312
• Report Number: 3010532612-2023-00124
• Device Sequence Number: 14860798
• Product Code: DSP
• UDI-Device Identifier: 10801902161960
• UDI-Public: 10801902161960
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: IPN915324
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F22G0050
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 60 KG