MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038077
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, two catheters consecutively would not fit through the sheath.As a result, a third catheter was used and was successful.All catheters were inserted at the same insertion site.No patient harm or injury.The patient status is reported as fine.See associated mdr 3010532612-2023-00196.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The serial number (b)(6) reported by the customer is an invalid serial number.The serial number of the returned sample is (b)(6).The lot number (18f22l0046) reported matches the lot number for the returned sample.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, the peel away sheath was noted on the returned iabc.The one-way valve was connected and tethered to the short driveline tubing.The iabc bladder was fully unwrapped.A kink to the iabc central lumen was noted near the iabc bifurcate at approximately 72.8cm 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.The sheath in question was not returned with the sample.A handwritten note was returned with the sample stating "balloon unwrapped upon opening package, catheter would not go through sheath".The bladder thickness was measured at six points with measurements ranging from 0.0074in-0.0078in and was within specification of process document.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 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 72.9cm from the iabc distal tip, which is the location of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris were noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 11.8cm from the iabc luer, which is the location of the previously noted kink.The guidewire was able to advance through the central lumen.No blood or debris were 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 unwrapped prematurely is confirmed.The iabc bladder was fully unwrapped upon receipt of the sample.The unwrapped bladder can result in difficulty advance the iabc into the sheath/patient.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 unwrapped bladder.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.
Event or Problem Description
It was reported that during insertion, two catheters consecutively would not fit through the sheath.As a result, a third catheter was used and was successful.All catheters were inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".See associated mdr 3010532612-2023-00196.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16659526
• Report Number: 3010532612-2023-00195
• Device Sequence Number: 1700628
• Product Code: DSP
• UDI-Device Identifier: 00801902136732
• UDI-Public: 00801902136732
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 11/30/2024
• Device Model Number: IPN038077
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22L0046
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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 Sex: Unknown