MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06850-U
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "sheath folded in on itself.Accordion style".Additional information states that to continue therapy, another iab c atheter was inserted.The second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Additional information from the customer states that " the iab failed to unfurl".An additional complaint has been created to capture this malfunction.Associated mdr# 3010532612-2024-00911.Returned for investigation was an 8.5fr sheath w/sidearm & dilator assembly from an insertion kit for a 50cc 8fr ultraflex intra-aortic balloon catheter (iabc).The sample was returned in a ups shipping box and was in a sealed bio-hazard bag.Upon return, the 8.5fr teflon sheath extrusion was noted buckled near the sheath tip; the location of the buckling was at approximate 1.4cm-1.6cm from the sheath tip.The sheath hub and tip appeared typical; no other damage was noted to the sheath.The dilator tip and hub appeared typical with no damage noted.Dried blood was noted within the sheath/dilator.The dilator was removed from the sheath without difficulty.The dilator was aspi-rated and flushed successfully; some blood was noted.The 8.5fr teflon sheath with sidearm was aspirated and flushed successfully; some blood 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 "sheath folded in" is confirmed.During the investigation, the sheath body was found buckled near the sheath tip.No other damage was noted to the sheath.Based on a re-view 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 buckled sheath.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "sheath folded in on itself.Accordion style".Additional information states that to continue therapy, another iab c atheter was inserted.The second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20383294
• Report Number: 3010532612-2024-00825
• Device Sequence Number: 8066111
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)230921(17)250831(10)18F23J0043(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23J0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: Unknown