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	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after 3 minutes of use, the machine frequently alarms that helium may leak.The adjustment equipment and the catheter cannot solve the problem.After the catheter is replaced, the problem is solved.In vitro experiment, it is determined that the connection hub of catheter leak".Additional information received stated that second iab was inserted at the same site.No patient injury, harm, or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The lot number reported on the complaint report does not match the lot number the returned sample.No serial number was reported.Additional information obtained 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) with an original packaging box that does not match the serial number on the returned sample.Returned with the sample were kit components including 40cc inflation driveline tubing, 0.025in guidewire and long arterial pressure tubing; no damage or abnormalities were noted to the returned components.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen within the flex-tip assembly area was noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 6.5cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned sample.Small amount of dried blood was also noted within the iabc bladder and flex-tip assembly.No other visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points.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.An attempt to aspirate and flush the iabc central lumen using a 60cc 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 damaged central lumen.The iabc was leak tested.A leak was immediately detected from the iabc distal tip and luer end.The leak noted from the iabc distal tip and luer end are consistent with the previously noted damaged iabc 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 guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the location of the flex-tip assembly separation while excreting blood within the bladder membrane.Blood was also noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire exited the central lumen and entered the bladder at the location of the inner cannula separation while excreting blood within the bladder membrane.Blood was also noted on the guidewire.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 iab helium loss alarm is confirmed.During the investigation, the iabc central lumen was noted damaged and found no longer attached to the central lumen flex tip assembly.The damaged central lumen will result in blood entering the helium pathway.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 damaged catheter.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported "after 3 minutes of use, the machine frequently alarms that helium may leak.The adjustment equipment and the catheter cannot solve the problem.After the catheter is replaced, the problem is solved.In vitro experiment, it is determined that the connection hub of catheter leak".Additional information received stated that second iab was inserted at the same site.No patient injury, harm, or consequence reported.Patient condition 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: 15452243
• Report Number: 3010532612-2022-00359
• Device Sequence Number: 6855398
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F21M0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown