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

Model Number	IPN915325
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the patient underwent a ptca with initiation of iabp and ecmo therapies."the surgeon implanted the balloon through a sheath and was unable to fully implant it into the ideal position.However, by moving the balloon back and forth, it was still unable to be implanted into the ideal position.Withdraw the balloon, connect the one-way valve, retract the exhaust, and insert it again, but it cannot be fully inserted.Immediately withdraw the balloon and discover that it has been folded." as a result, a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No serial number was reported.The serial number on the returned sample is by30745.The reported lot number (18f23b0026) matches the lot number for the returned original packaging box and for the returned sample.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Upon return, an ap tubing was noted connected to the iabc luer end.The supplied 40cc inflation driveline tubing was connected to the iabc short driveline tubing; no damage or abnormality was noted with the driveline tubing.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Kinks were noted to the central lumen at approximately 2.6cm and 6.7cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the iabc; no blood was noted within the helium pathway.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 in accordance with quality system document q-96.The catheter's central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.The iabc was leak tested using the lt-l-015 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.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 2.5cm and 6.6cm from the iabc distal tip, which are the location of 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 77.9cm and 82cm from the iabc luer, which are the location of previously noted bends.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 insertion difficulty is confirmed.The intra-aortic balloon catheter (iabc) was returned with kinks to the central lumen.The damaged iabc can result in difficulty inserting the iabc into the patient.The returned iabc bladder membrane passed inspection.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 kinked central lumen.The root cause of the kinks is undetermined.A most probable potential cause is customer handling.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 the patient underwent a ptca with initiation of iabp and ecmo therapies."the surgeon implanted the balloon through a sheath and was unable to fully implant it into the ideal position.However, by moving the balloon back and forth, it was still unable to be implanted into the ideal position.Withdraw the balloon, connect the one-way valve, retract the exhaust, and insert it again, but it cannot be fully inserted.Immediately withdraw the balloon and discover that it has been folded." as a result, a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• 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: 17353173
• Report Number: 3010532612-2023-00395
• Device Sequence Number: 17652752
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: 10801902161977
• 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): 06/29/2023

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: 01/31/2025
• Device Model Number: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F23B0026
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 59 KG