MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN915322
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that after placement of the catheter the patient was transferred to the icu.The next day, blood was found in the helium tube.The catheter was removed.The catheter was not replaced.A different therapy was initiated on the patient.No report of patient injury or harm.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).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 (18f22f0065) for the returned sample.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.Returned with the sample was a data-scope driveline tubing; some dried blood was noted within the tubing.The tubing and its components were visually inspected with no damage or abnormality.Upon return, the distal end of the teflon sheath was noted at approximately 43.7cm from the iabc luer end; some clear liquid was noted within the sheath sidearm.The one-way valve was tethered to the iabc short driveline tubing.The bladder was fully unwrapped.Bends to the iabc were noted at approximately 18cm and 24.5cm from the iabc distal tip.The iabc central lumen was noted kinked and b roken within the flex-tip assembly area at approximately 5.6cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Some dried blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0063in-0.0065in.The one-way valve was tested.A vacuum was pulled on the one-way valve, and it slowly lost pressure.This test was repeated with similar results.No obvious blood or debris was noted within the one-way valve upon cleaning.The one-way valve was properly cleaned and tested again; the one-way valve slowly lost pressure and failed.An attempt to aspirate and flush the iabc central lumen using a lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted broken central lumen.The iabc was leak tested.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.5cm, 23.2cm and 24.2cm from the iabc distal tip, which are the locations of the previously noted bend and kink/broken central lumen.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 53cm, 57cm, 58.3cm and 77cm from the iabc luer.The guidewire was able to advance through the central lumen.No blood or debris was noted.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 for iab blood in helium pathway is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which caused blood to enter the helium pathway.The returned iabc bladder membrane was fully intact, with no leaks 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 broken central lumen.The root cause of the broken central lumen is undetermined.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that after placement of the catheter the patient was transferred to the icu.The next day, blood was found in the helium tube.The catheter was removed.The catheter was not replaced.A different therapy was initiated on the patient.No report of patient injury or harm.The patient status 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16122439
• Report Number: 3010532612-2023-00017
• Device Sequence Number: 6547984
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• 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
• 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: 05/31/2024
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22F0065
• 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: 02/28/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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 Sex: Unknown