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

Model Number	IPN915321
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that after the catheter was implanted during the operation, the balloon catheter was found ruptured.As a result, a new iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.There are no available photographs.
Additional Manufacturer Narrative
(b)(4), the sample returned for this investigation was deemed as representative sample, as was returned completely sealed/unused.Additional information was received stating the device in question is not available for the investigation.No serial number was reported.The serial number on the returned sample is (b)(6).The lot number 18f22f0020 recorded on the complaint report matches the lot number for the returned sample and on the returned packaging box.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.The sample was returned in a cardboard box and was in the original packaging box/yellow bio-hazard bag.Returned with the sample were semi-finished insertion kit components including 0.025" guidewire, 8fr teflon sheath w/dilator assembly and 8fr teflon sheath w/ sidearm and dilator assemb ly; no damage or abnormalities were noted to the returned components.The returned 8fr teflon sheath w/dilator assembly and 8fr teflon sheath w/ sidearm and dilator assembly appeared unused.Upon return, the semi-finished kit was noted completely sealed and unused.The peel away sheath was noted on the returned iabc.The one-way valve was tethered to the short driveline tubing.The stylet was noted fully inserted within the iabc central lumen.The bladder was noted fully inserted within the original packaging tray.No blood was noted on the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points 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 in accordance with quality system document q-96.The one-way valve was connected to the iabc short driveline tubing, and a negative vacuum was pulled on the iabc.While maintaining the negative vacuum, the iabc was removed from the original packaging tray without any difficulty.Upon removal of the iabc, no damage or abnormalities were noted to the iabc; the iabc bladder was fully wrapped.The stylet was removed from the iabc central lumen without any difficulty.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested using the mdt-50 in accordance with testing methods from manufacturing procedure 21-7214 rev.15.No leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with the returned 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; 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.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk is acceptable.The returned device passed visual and functional testing.The reported complaint that the "balloon catheter was found ruptured" is not confirmed.A representative sample was received for the investigation.The returned sample was completely sealed/unused.The device in question was not returned for the investigation.The returned intra-aortic balloon catheter (iabc) was functionally tested with no leaks or alarms noted.The root cause of the complaint is undetermined.No further action required at this time.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15523090
• Report Number: 3010532612-2022-00386
• Device Sequence Number: 14950045
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: IPN915321
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22F0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown