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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 50cc 8.0fr ultraflex intra-aortic balloon catheter (iabc).Upon return, the supplied teflon sheath was noted on the returned sample.The one-way valve was tethered to the short driveline tubing.The distal and proximal portion of the iabc bladder was noted wrapped (or considered twisted); the middle portion of the iabc bladder was noted fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0068in-0.0075in 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.Some blood exited.The iabc was leak tested.During the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated but the distal and proximal portion of the bladder would not fully unwrap and was consistent with being twisted.No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the 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 for iab "did not unwrap at distal tip" is confirmed.During the investigation, the distal and proximal portion of the iabc bladder was noted twisted.During functional testing, the bladder would not fully inflate or unwrap.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 twisted bladder.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to further investigate the issue.
Event or Problem Description
It was reported "iab did not unwrap at distal tip".To continue therapy, the iab catheter was removed and replaced.The second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "critical".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 50cc 8.0fr ultraflex intra-aortic balloon catheter (iabc).Upon return, the supplied teflon sheath was noted on the returned sample.The one-way valve was tethered to the short driveline tubing.The distal and proximal portion of the iabc bladder was noted wrapped (or considered twisted); the middle portion of the iabc bladder was noted fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0068in-0.0075in 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.Some blood exited.The iabc was leak tested.During the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated but the distal and proximal portion of the bladder would not fully unwrap and was consistent with being twisted.No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the 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 evice passed all manufacturing specifications prior to release.The reported complaint for iab "did not unwrap at distal tip" is confirmed.During the investigation, the distal and proximal portion of the iabc bladder was noted twisted.During functional testing, the bladder would not fully inflate or unwrap.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 twisted bladder.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to further investigate the issue.
Event or Problem Description
It was reported "iab did not unwrap at distal tip".To continue therapy, the iab catheter was removed and replaced.The second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "critical".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20160051
• Report Number: 3010532612-2024-00739
• Device Sequence Number: 17983368
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)231205(17)251130(10)18F23L0058(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 11/30/2025
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23L0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 98 KG