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

Model Number	IPN039778
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the catheter was found to be kinked during use on a patient.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number ((b)(6)) recorded on the complaint report matches the serial number on the returned sample.The reported lot number (18f22g0001) matches the lot number for the returned sample.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with an original packaging carton that does not match the serial number/lot number of the returned sample.Returned with the sample were original packaging trays with some supplied components including the short ap tubing, long ap tubing, 40cc inflation driveline tubing, two 0.025in guidewires, scalpel, needle, pre-dilator, and two 8fr sheath/dilator assemblies; all components were inspected, and no abnormalities were noted.Upon return, the one-way valve was tethered to the iabc short driveline tubing.The bladder was fully unwrapped.A bend to the iabc were noted at approximately 9.6cm from the iabc distal tip.The iabc central lumen was noted kinked and broken within the flex-tip assembly area at approximately 5.8cm from the iabc distal tip.A small amount of dried blood was noted on the exterior surfaces of the returned sample; no 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 and then 30 seconds five separate times.An attempt to aspirate and flush the iabc central lumen using a lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The results are consistent with the previously noted broken central lumen.The iabc was leak tested.15.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.The returned 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance at approximately 1.7cm and the guidewire could not advance at approximately 5.9cm from the iabc distal tip.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance at approximately 67.8cm from the iabc luer end.The guidewire could not advance at approximately 71.8cm from the iabc luer end.No blood or debris was noted.A device history record (dhr) review was conducted for the lot nu mber with no relevant findings.The device passed all manufacturing specifications prior to release.A non-conformance has been initiated to further investigate the issue.The reported complaint of iab kinked is confirmed.During the investigation, the central lumen was broken near the iabc distal tip which may have been the result of a kinked catheter.The damaged iabc can cause the complaint.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 broken central lumen.The root cause of the broken central lumen is undetermined.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the catheter was found to be kinked during use on a patient.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16537035
• Report Number: 3010532612-2023-00159
• Device Sequence Number: 6325478
• Product Code: DSP
• UDI-Device Identifier: 10801902145618
• UDI-Public: 10801902145618
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Expiration Date: 06/30/2024
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22G0001
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• Patient Sex: Unknown