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

Catalog Number IAB-S840C

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that, "during pci, the patient's blood pressure decreased and an iabp catheter was inserted to assist.It is difficult when the doctor insert the catheter into the sheath, and after inserted, there is no blood pressure waveform.The ap cannot be triggered.The catheter was withdrawn and replaced with another iab-s840c, iabp assistance was initiated, and the surgery was successfully completed".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, "during pci, the patient's blood pressure decreased and an iabp catheter was inserted to assist.It is difficult when the doctor insert the catheter into the sheath, and after inserted, there is no blood pressure waveform.The ap cannot be triggered.The catheter was withdrawn and replaced with another iab-s840c, iabp assistance was initiated, and the surgery was successfully completed".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint that "there is no blood pressure waveform" was confirmed upon investigation of the returned sample.The customer returned a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging for investigation.Upon return, the one-way valve was tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped (inp-6).Two kinks to the iabc central lumen were noted at approximately 12.3cm and 13.5cm from the iabc distal tip (inp-7).Dried blood was noted on the exterior of the returned iabc.During visual inspection of the bladder, it was noted that the proximal end of the bladder was no longer attached to the iabc outer lumen (inp-8 through inp-11).Evidence of previous lamination was noted on the iabc outer lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the outer lumen/proximal end of the bladder membrane (anp-1).The leak was consistent with the bladder not attached to the outer lumen (inp-8 th rough inp-11).No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 12.3cm and 13.6cm from the iabc distal tip, which are the locations of the 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 71.4cm and 72.7cm from the iabc luer, which are the locations of the previously noted kinks.The guidewire was able to advance through the central lumen.No blood or debris was noted.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 complaint was undetermined.A most probable potential cause is customer handling.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.The associated mdr number for this complaint is 3010532612-2023-00540.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17746722
• MDR Text Key: 323420928
• Report Number: 3010532612-2023-00537
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22K0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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