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

Model Number	IPN915324
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that a leak was found on a catheter while in use on a patient.Therefore, a second catheter was inserted at the same insertion site.The report states, "the patient was critical prior to the event" and that "the patient is in the icu, the current condition is critical".
Additional Manufacturer Narrative
Qn# (b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f22e0021) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number on the returned sample.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Numerous kinks to the iabc central lumen were noted at approximately 16.2cm, 16.8cm and 17.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0066in-0.0070in.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.Some blood exited.The iabc was leak tested.Multiple leaks were immediately detected from the bladder membrane.Un der microscopic inspection, a total of 4 repeated leak sites consistent with contact from a sharp object were noted; a total of three (3) repeated leak sites were noted around the circumference of the bladder at approximately 2.2cm from the iabc distal tip, and one (1) leak site was noted at approximately 2.8cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 16cm, 16.7cm and 17.5cm from the iabc distal tip, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 67.6cm, 68.3cm and 69cm from the iabc luer, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.Some blood was noted on the guidewire.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 that the "catheter leak during used on the patient" is confirmed.During the investigation, numerous punctures consistent with contact from a sharp object, were found on the iabc bladder membrane, which caused the reported complaint.No other leaks were detected during functional testing.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 bladder leaks.The root cause of the bladder leak is undetermined.T he most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It is reported that a leak was found on a catheter while in use on a patient.Therefore, a second catheter was inserted at the same insertion site.The report states, "the patient was critical prior to the event" and that "the patient is in the icu, the current condition is critical".

• 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: 16074835
• Report Number: 3010532612-2022-00583
• Device Sequence Number: 17715742
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 04/30/2024
• Device Model Number: IPN915324
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F22E0021
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 57 KG