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

Model Number	IPN039778
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that "the balloon ruptured during use on the patient.As a result, a new iab was used and inserted at the same insertion site.There was no report of patient complications, serious injury or death".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states that "the balloon ruptured during used on the patient.As a result, a new iab was used and inserted at the same insertion site.There was no report of patient complications, serious injury or death.".
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.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number for the returned sample.The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Returned with the sample was the supplied 30cc driveline tubing, a 60cc syringe, the short arterial pressure tubing, two 0.025in guidewires, and two teflon sheaths.Upon return, the distal end of the teflon sheath was at approximately 41cm from the iabc distal tip; blood was noted within the sheath sidearm.The teflon sheath was noted connected to the hemostasis cuff.The datascope driveline tubing was noted connected to the short driveline tubing.The short arterial pressure tubing was noted connected to the iabc luer.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 9.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0058in-0.0064in and was within specification.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.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested and a leak was immediately detected from the bladder membrane.Under microscopic inspection, the leak site is consistent with contact from a sharp object and was noted at approximately 21.8cm to 22cm from the iabc distal tip.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance and could not advance at approximately 9.5cm from the iabc distal tip; which is the location of the previously noted bend.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 68.8cm from the iabc luer; which is the location of the previously noted bend.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 "the balloon ruptured" is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iabc bladder and this caused the reported complaint.No other leaks were detected during functional testing.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 leak.The root cause of the bladder leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
The report states that "the balloon ruptured during used on the patient.As a result, a new iab was used and inserted at the same insertion site.There was no report of patient complications, serious injury or death.".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15625150
• Report Number: 3010532612-2022-00407
• Device Sequence Number: 6345104
• 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,Followup
• Report Date (Section B): 09/22/2022

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: 05/31/2024
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22F0034
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 03/19/2024
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/10/2022; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 55 KG