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

Model Number	IPN915322
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending, and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the alleged 40cc iab catheter connected to a cardiosave iabp had been put in the patient since 15 nov.An alarm of gas loss in iab circuit first appeared on 24 nov, but no blood was found in the helium tubing and different alarms were activated since then.The user reported no kinking of the catheter.To retrieve the alarm history, the user changed the connection of the alleged catheter to another cardiosave iabp unit on 25 nov and gas loss alarm still appeared.On 26 nov, the physician withdrew the alleged iab catheter with the sheath as a whole and exchanged for a new iab catheter for the patient to continue the iabp circulatory support.There was no reported patient injury.
Event or Problem Description
It was reported that the alleged 40cc iab catheter connected to a cardiosave iabp had been put in the patient since 15 nov.An alarm of gas loss in iab circuit first appeared on 24 nov, but no blood was found in the helium tubing and different alarms were activated since then.The user reported no kinking of the catheter.To retrieve the alarm history, the user changed the connection of the alleged catheter to another cardiosave iabp unit on 25 nov and gas loss alarm still appeared.On 26 nov, the physician withdrew the alleged iab catheter with the sheath as a whole and exchanged for a new iab catheter for the patient to continue the iabp circulatory support.There was no reported patient injury.
Additional Manufacturer Narrative
(b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the distal end of the teflon sheath was noted at approximately 44cm from the iabc distal tip.A non-teleflex extension tubing was noted connected to the teflon sheath sidearm; clear fluid was noted within the sheath sidearm/extension tubing.The one-way valve was tethered to the short driveline tubing.The supplied short arterial pressure tubing was noted connected to the iabc luer end; clear fluid was noted within the ap tubing.The bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 24.3cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.The customer photos were reviewed.One picture showed an alarm log from a display screen of a competitor iabp (maquet/datascope); the alarm log showed various alarms including "gas loss in iab circuit" alarms.This is consistent with the reported event.The second picture shows an iabc which matched the returned sample for the investigation.The bladder thickness was measured at six points with measurements ranging from 0.0058in-0.0065in.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.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 not confirmed.The returned iabc was functionally tested with no leak or abnormalities noted.No alarms w ere noted during the functional testing.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.

• 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 ; 9194332672
• MDR Report Key: 16014487
• Report Number: 3010532612-2022-00540
• Device Sequence Number: 6655139
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2022

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: 03/31/2024
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22D0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown