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 Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch "per the report this was a faulty balloon pump, balloon under expanded during inflation.Cath lab staff were aware of the potential due to previously reported fda and device alerts.So, they changed to a new balloon pump." additional information states that the patient was "discharged from the hospital alive, exepected to fully recover." at the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Returned for investigation was a 50 cc 8fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed biohazard bag.Upon return, the teflon sheath was noted on the returned sample; liquid blood was noted within the sheath sidearm.The one-way valve was connected and tethered to the short driveline tubing.The distal portion of the iabc bladder was noted wrapped (or considered twisted); the remaining portion of the iabc bladder was noted fully unwrapped.Dried blood was noted on the exterior sur-faces of the returned sample.No blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0065 in to 0.0075 in and was within sp specification of process document.The iabc central lumen was aspirated and flushed using a 60 cc lab-inventory syringe.Blood exited.The iabc was leak tested in accordance with testing methods from manufacturing procedure.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 un-wrap and was consistent with being twisted.No leaks were detected.A lab inventory 0.025 in guide-wire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood was noted on the guidewire upon removal.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 "balloon under expanded during inflation" 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 via medwatch "per the report this was a faulty balloon pump, balloon under expanded during inflation.Cath lab staff were aware of the potential due to previously reported fda and device alerts.So, they changed to a new balloon pump".Additional information states that the patient was "discharged from the hospital alive, exepected to fully recover".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• 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: 20481131
• Report Number: 3010532612-2024-00877
• Device Sequence Number: 12828796
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)230206(17)250131(10)18F23B0010(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 01/31/2025
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23B0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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