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

Catalog Number	IAB-S840C
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that, "during the passage of the catheter it did not progress in the introducer, another unsuccessful attempt was made and after it was decided to interrupt the procedure." the hospital did not have a 2nd catheter to attempt another insertion.The procedures being performed in conjunction with the iab insertion were a primary angioplasty and arterial recanalization due to an acute myocardial infarction.Additional information received states that the patient expired two hours after the issue occurred.The cause of death is reported as severe ventricular failure and cardiogenic shock secondary to acute myocardial infarction.
Additional Manufacturer Narrative
(b)(4).The reported complaint that "during the passage of the catheter it did not progress in the introducer" 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.A kink to the iabc central lumen was noted at approximately 53.2cm from the iabc luer.Bends to the iabc central lumen were noted at approximately 11.9cm and 12.6cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.During the functional inspection, resistance was noted upon passing the guidewire through the iabc central lumen.The damaged iabc can result in difficulty inserting the iabc through a sheath.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 damaged catheter.The root cause was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that, "during the passage of the catheter it did not progress in the introducer, another unsuccessful attempt was made and after it was decided to interrupt the procedure." the hospital did not have a 2nd catheter to attempt another insertion.The procedures being performed in conjunction with the iab insertion were a primary angioplasty and arterial recanalization due to an acute myocardial infarction.Additional information received states that the patient expired two hours after the issue occurred.The cause of death is reported as severe ventricular failure and cardiogenic shock secondary to acute myocardial infarction.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17444249
• Report Number: 3010532612-2023-00419
• Device Sequence Number: 2735949
• Product Code: DSP
• UDI-Device Identifier: 00801902136732
• UDI-Public: 00801902136732
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F22K0028
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 62 KG