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

Model Number	IPN915321
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the pump was started and pumped properly for approximately 3 minutes.Then there was blood found in the helium tube.The balloon had ruptured.The balloon catheter was removed and a new one was inserted at the same insertion site.After the new balloon catheter was inserted, the pump was restarted and began pumping normally.No report of patient harm or injury.Patient status is reported as "fine".
Event or Problem Description
It was reported that the pump was started and pumped properly for approximately 3 minutes.Then there was blood found in the helium tube.The balloon had ruptured.The balloon catheter was removed and a new one was inserted at the same insertion site.After the new balloon catheter was inserted, the pump was restarted and began pumping normally.No report of patient harm or injury.Patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#: (b)(4).The reported complaint for iab blood in helium pathway is confirmed.Sample was returned to our manufacturing site for investigation.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a carboard box and was in a plastic bag.No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f22e0065) reported on the complaint report does not match the lot number for the returned sample.The lot number for the returned sample is 18f22g0001.According to the additional information received, the sample is correct for this complaint.Upon return, the one-way valve was tethered to the short driveline tubing.The supplied 30cc inflation driveline tubing was connected to the short driveline tubing; blood was noted within the helium pathway.The iabc bladder was loosely wrapped.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 with measurements ranging from 0.0063in-0.0068in and was within specification of process document.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 internal quality system document.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed and pushback was noted; the central lumen was likely blocked by a blood clot.Another attempt to aspirate and flush the catheter was successfully completed after clearing the blood clot.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the b ladder membrane.Under microscopic inspection, the leak site is consistent with contact from a sharp object and was noted at approximately 22.7cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.Resistance was noted at approximately 55.8cm from the iabc distal tip.The guidewire exited through the iabc luer while excreting blood before exiting.Some blood was noted on the guidewire upon removal.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 21.8cm from the iabc luer end.The guidewire exited through the iabc distal tip while excreting blood before exiting.Some blood was noted on the guidewire upon removal.In summary, during the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found near the proximal end of the iabc bladder.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.Teleflex will continue to monitor and trend for reports of this nature.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16114040
• Report Number: 3010532612-2023-00015
• Device Sequence Number: 6961709
• Product Code: DSP
• UDI-Device Identifier: 10801902161939
• UDI-Public: 10801902161939
• 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): 01/04/2023

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: IPN915321
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 51 KG