MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039788
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "wuhan asian heart hospital encountered very serious resistance when withdrawing the catheter and the catheter was unable to take out.Dsa showed that there was a problem with the balloon tip.After that, the patient was immediately transferred to surgery to open the artery and take out the catheter".Additional information received stated that another iab was not inserted.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).No serial number was reported.The serial number of the returned device is unknown.The bifurcate was not returned with the device, therefore the serial number of the device cannot be determined.Returned for investigation was a 40cc 7.5fr ultra flex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the sample was received without the bifurcate, luer, short driveline tubing, and one-way valve.The returned device was in two separate sections.The first section included the iab central lumen, outer lumen, and bladder.The second section included the iabc distal tip and a section of the central lumen.The central lumen was noted broken from the iab distal tip.The bladder was fully unwrapped and was noted cut/torn at approximately from the distal end of the bladder.During visual inspection of the bladder tip, it was noted the distal end of the bladder was no longer attached to the iabc distal tip.Evidence of previous lamination was noted on the iabc distal tip.Blood was noted on the exterior surfaces of the returned iabc as well as within the helium pathway.The bladder thickness was measured at six points.Functional testing of the device was unable to be performed due to the returned state of the device.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 "problem with the balloon tip" is confirmed.Upon return, the distal tip of the iabc was noted detached from the bladder.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 bladder not attached to the distal tip.The root cause is manufacturing related.Corrections have been established for this issue and this device was manufactured prior to the release of those corrections.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported "wuhan asian heart hospital encountered very serious resistance when withdrawing the catheter and the catheter was unable to take out.Dsa showed that there was a problem with the balloon tip.After that, the patient was immediately transferred to surgery to open the artery and take out the catheter".Additional information received stated that another iab was not inserted.Patient condition reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15442706
• Report Number: 3010532612-2022-00354
• Device Sequence Number: 5672920
• Product Code: DSP
• UDI-Device Identifier: 10801902145731
• UDI-Public: 10801902145731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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
• Device Expiration Date: 02/28/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22C0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown