MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "patient condition deteriorated further in icu around 4am and emergency angiogram was done around 5am.Diagnosis stemi, patient in cardiogenic shock.Sheath was placed and guidewire was advanced with no challenges.Cardiologists experience resistance with placing iab cath via sheath (provided in set) over guidewire (provided in set), another iab30cc kit was opened, and 2nd catheter was inserted successfully.Critical ill patient was taken back to icu with support of iabp but unfortunately passed away a few hours later in icu".The report further states "patient was critically ill before iabp was inserted" and "another iab catheter was placed (only few minutes delay in fetching 2nd product off shelf and preparing for insertion)".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient condition deteriorated further in icu around 4am and emergency angiogram was done around 5am.Diagnosis stemi, patient in cardiogenic shock.Sheath was placed and guidewire was advanced with no challenges.Cardiologists experience resistance with placing iab cath via sheath (provided in set) over guidewire (provided in set), another iab30cc kit was opened, and 2nd catheter was inserted successfully.Critical ill patient was taken back to icu with support of iabp but unfortunately passed away a few hours later in icu".The report further states "patient was critically ill before iabp was inserted" and "another iab catheter was placed (only few minutes delay in fetching 2nd product off shelf and preparing for insertion)".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The serial number of the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the re turned sample is the correct iabc for this complaint.Re-turned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a bio-hazard bag.Upon return, the stylet was noted inserted in the iab central lumen.The peel-away sheath was noted on the returned iabc.The one-way valve was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.No blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.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 according to quality system document.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detect-ed.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; 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 "resistance with placing iab cath via sheath (provided in set) over guidewire" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient condition deteriorated further in icu around 4am and emergency angiogram was done around 5am.Diagnosis stemi, patient in cardiogenic shock.Sheath was placed and guidewire was advanced with no challenges.Cardiologists experience resistance with placing iab cath via sheath (provided in set) over guidewire (provided in set), another iab30cc kit was opened, and 2nd catheter was inserted successfully.Critical ill patient was taken back to icu with support of iabp but unfortunately passed away a few hours later in icu".The report further states "patient was critically ill before iabp was inserted" and "another iab catheter was placed (only few minutes delay in fetching 2nd product off shelf and preparing for insertion)".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23391655
• Report Number: 3010532612-2025-01056
• Device Sequence Number: 10052676
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250409(17)270228(10)18F25C0047(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2025

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 Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25C0047
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 02/25/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/27/2025; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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 Age: 68 YR
• Patient Sex: Female