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

Model Number	IPN038077
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while in use on a patient, the catheter ruptured.As a result, the catheter was removed and a 2nd catheter was inserted at a different insertion site.No patient harm or injury.The current status of the patient is "improving slowly, has had bypass surgery and weaned off the 2nd iabp".
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient, the catheter ruptured.As a result, the catheter was removed and a 2nd catheter was inserted at a different insertion site.No patient harm or injury.The current status of the patient is "improving slowly, has had bypass surgery and weaned off the 2nd iabp".
Additional 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).Additional information obtained during a follow up indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a supplied return kit and was in a sealed biohazard bag.Returned with the sample was a datascope driveline tubing; some dried blood was noted within the tubing.Upon return, the distal end of the teflon sheath was noted at approximately 28.2cm from the iabc distal tip.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 iabc bladder was fully unwrapped.Bends were noted to the central lumen at approximately 1.7cm, 5.2cm , and 7.6cm from the iabc distal tip.A bend was also noted to the iabc at approximately 47cm from the iabc distal tip.A kink was noted to the iabc at approximately 72.2cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc 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 iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris 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 obvious leaks were initially noted; however, during leak testing additional damage occurred, by accident, due to sample handling.The iabc central lumen had completely broken, at approximately 1.6cm from the iabc distal tip.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no leaks were detected.Upon review of the visual and functional testing results, the most likely cause of the blood entering the helium pathway was a crossover leak from a damaged central lumen.The dried blood noted in the helium pathway was noted with more build up of dried blood in the distal portion of the iabc bladder.No leaks or damage was noted to the iabc bladder.Due to the initial leak test results and damage which occurred during the investigation, the actual crossover site is unable to be determined.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the noted central lumen break.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 9.6cm from the iabc luer, which is the location of a previously noted kink.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 leak suspected is confirmed based on visual inspection.Blood was confirmed within the helium pathway.Various damages to the central lumen were noted; however, during functional testing the central lumen was unintentionally broken from sample handling.Upon review of the visual inspection and initial functional testing, it was likely a crossover leak from a damaged central lumen which caused blood to enter the helium pathway.The actual crossover site is unable to be determined.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 damages to the central lumen upon return.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.

• 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: 16953708
• Report Number: 3010532612-2023-00268
• Device Sequence Number: 3300992
• Product Code: DSP
• UDI-Device Identifier: 00801902136732
• UDI-Public: 00801902136732
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/26/2023

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-06840-U
• Device Lot Number: 18F22M0015
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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: Male
• Patient Weight: 76 KG