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

Model Number	IPN039788
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after the catheter was implanted during the operation, the machine alarmed (gas leak alarm).After the catheter was taken out, the catheter was found leakage".Additional information stated that the catheter was replaced with a new iab.The new iab was inserted at the same insertion site.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "after the catheter was implanted during the operation, the machine alarmed (gas leak alarm).After the catheter was taken out, the catheter was found leakage".Additional information stated that the catheter was replaced with a new iab.The new iab was inserted at the same insertion site.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 7.5fr ultra flex intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number on the returned sample.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned iabc; no obvious blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned sample.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 in accordance with the quality system document.The iabc central lumen was aspirated and flushed.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from the manufacturing procedure.A leak was immediately noted and located around the bifurcate bushing bond.Upon microscopic inspection, the leak occurred from the adhesive bond at the bifurcate bushing.No other leaks were detected.A 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.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris were 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 helium loss alarm is confirmed.During the complaint investigation, an external leak is confirmed from the intra-aortic balloon catheter (iabc) bifurcate bushing adhesive.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 external leak from the iabc bifurcate bushing adhesive.The root cause is manufacturing related.A non-conformance has been initiated to further investigate the issue.

• 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: 15442705
• Report Number: 3010532612-2022-00355
• Device Sequence Number: 5672919
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22D0002
• 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: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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
• Patient Sex: Unknown