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	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the balloon was implanted, the machine was started, after 2 minutes the alarm "helium leakage" occurred.The problem was solved after replacing the catheter".Additional information received stated that the iab catheter was placed in the left femoral artery.No patient injury, harm, or consequence from replacing the catheter.Patient condition was reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when the balloon was implanted, the machine was started, after 2 minutes the alarm "helium leakage" occurred.The problem was solved after replacing the catheter".Additional information received stated that the iab catheter was placed in the left femoral artery.No patient injury, harm, or consequence from replacing the catheter.Patient condition was reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab helium loss alarm is confirmed.The sample was returned to the manufacturer for investigation.The lot number (18f22c0020) reported on the complaint report does not match the lot number (18f22c0035) for the returned sample.No serial number was reported.The serial number of the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the 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 plastic bag.Upon return, the peel-away sheath was on the iabc and connected to the hemostasis cuff.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Bends to the iabc were noted at approximately 24.0cm and 61.2cm from the iabc distal tip.A dried yellow media was noted on the exterior of the iabc.Spots of dried blood was noted on the exterior surfaces of the returned iabc; 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 in accordance with internal quality system document.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 using testing methods from internal manufacturing procedure.An external leak was immediately noted and loc ated 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 lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 24.2cm and 60.4cm from the iabc distal tip, which are the locations of the previously noted bends.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.Resistance was noted at approximately 22.2cm and 58.2cm from the iabc luer, which are the locations of the previously noted bends.The guidewire was able to advance through the central lumen.No blood or debris was noted.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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15317301
• Report Number: 3010532612-2022-00328
• Device Sequence Number: 5124719
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 02/28/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22C0035
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: PUMP.; PUMP.
• Patient Sex: Unknown