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	09/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after 3 minutes of use, the machine frequently alarmed for helium loss.The issue could not be resolved by adjusting the equipment and the catheter.As a result, the catheter was replaced, and the problem was solved".Additional information states that the secondary catheter was inserted at the same insertion site.The patient condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after 3 minutes of use, the machine frequently alarmed for helium loss.The issue could not be resolved by adjusting the equipment and the catheter.As a result, the catheter was replaced, and the problem was solved".Additional information states that the secondary catheter was inserted at the same insertion site.The patient condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4) the lot number for the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the r returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a bio-hazard bag.Returned with the sample was supplied data-scope inflation driveline tubing; blood was noted within the interior surfaces of the retuned data-scope inflation driveline tubing.Upon return, the device was in four separate sections.The total length of the first section was approximately 11.3cm and included the iabc distal tip, portion of the iabc bladder and flex-tip assembly (part of the iabc inner cannula).The flex-tip assembly was noted separated and no longer attached to the iabc central lumen.The remaining length of the iabc central lumen (inner cannula) was not returned with the sample.The flex-tip assembly was noted broken at approximately 1.3cm from the iabc distal tip.The iabc bladder was noted damaged; the damage to the iabc bladder appears consistent with being cut.Spots of dried blood were noted on the interior and exterior surfaces.The total length of the second section was approximately 39cm and included the portion of the iabc bladder and a portion of the iabc outer lumen.The remaining portion of the iabc bladder was not returned with the sample.The outer lumen was noted damaged at multiple locations and the damage appears consistent with being crushed.The iabc bladder was noted damaged; the damage to the iabc bladder appears consistent with being cut.Spots of dried blood were noted on the interior and exterior surfaces.The total length of the third section was approximately 18.5cm and included the iabc outer lumen.The outer lumen was noted damaged; the damage to the iabc outer lumen appears consistent with being cut.Spots of dried blood were noted on the interior and exterior surfaces.The fourth section included the iabc bifurcate, short driveline tubing and one-way valve.The central/outer lumen was noted damaged near the bifurcate bushing; the damage appears consistent with being cut.The one-way valve was connected and tethered to the short driveline tubing.Dried blood was noted on the exterior surfaces of the returned section.Dried blood was noted within the short driveline tubing/helium pathway.The bladder thickness was measured on the returned portions of the bladder at six points with measurements ranging from 0.0054in-0.0061in and was within specification of process document.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 that the "machine frequently alarmed for helium loss" is confirmed based on the visual inspection.Upon return, blood was confirmed within the iabc helium pathway.A helium pathway leak can cause the helium loss alarms.Furthermore, the device was returned cut in multiple areas and in 4 separate sections.Due to the returned state of the device, it could not be confidently determined what initially caused the reported 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 damaged catheter.The root cause of the complaint is undetermined.This will be monitored for any developing trends.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "after 3 minutes of use, the machine frequently alarmed for helium loss.The issue could not be resolved by adjusting the equipment and the catheter.As a result, the catheter was replaced, and the problem was solved".Additional information states that the secondary catheter was inserted at the same insertion site.The patient condition is 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15726315
• Report Number: 3010532612-2022-00463
• Device Sequence Number: 17954821
• Product Code: DSP
• UDI-Device Identifier: 10801902145731
• UDI-Public: (01)10801902145731(11)220523(17)240430(10)18F22E0046(21)
• 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,Followup
• Report Date (Section B): 10/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22E0046
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 09/24/2024
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/06/2022; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 59 KG