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

Catalog Number IAB-S840C

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "after insertion of a balloon catheter, a machine alarm was found, and after removal, blood leakage from the balloon was found, and the patient's counterpulsation was normal after replacement with a new catheter".The 2nd iab was inserted at the same insertion site.Additional information states that there was no patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).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.Returned with the sample were supplied kit components including 40cc inflation driveline tubing, 9fr super arrow-flex (saf) sheath and data-scope inflation driveline tubing.The returned 9fr super arrow-flex (saf) sheath appeared used; dried blood was noted on the exterior surfaces of the saf sheath and clear fluid was noted within the sheath sidearm.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Multiple bends to the iabc central lumen, consistent with flattened surfaces, were noted at approximately 55.5cm, 56.1cm and 57.8cm 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 bladder thickness was measured at six points with measurements ranging from 0.0070in-0.0077in and was within specification.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 a leak was immediately detected from the bladder membrane.Under microscopic inspection, a puncture on the iabc bladder, consistent with contact from a sharp object, was noted at approximately 24.2cm 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 55.5cm, 56.2cm and 58cm from the iabc distal tip, which are the locations of the previously noted flattened surfaces.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 27.2cm, 28.6cm and 29.2cm from the iabc luer, which are the locations of the previously noted flattened surfaces.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 that "blood leakage from the balloon was found" is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found on the iabc bladder which caused the reported complaint and allowed blood to enter the helium pathway.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 leak.The root cause of the bladder leak is undetermined.The 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.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "after insertion of a balloon catheter, a machine alarm was found, and after removal, blood leakage from the balloon was found, and the patient's counterpulsation was normal after replacement with a new catheter".The 2nd iab was inserted at the same insertion site.Additional information states that there was no patient harm or injury.The patient status is reported as "fine".

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: 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: 18903393
• MDR Text Key: 337744779
• Report Number: 3010532612-2024-00204
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F23G0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1