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

Model Number	IPN038074
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending, and the results will be submitted in a follow-up report.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the user inserted the sheath from the femoral and delivered the catheter to the desired position.Then attempted to begin pumping, but the balloon did not inflate.Therefore, the catheter was promptly removed and replaced in the same site with a new one, with which the iabp worked normally.There was no reported injury.
Event or Problem Description
It was reported that the user inserted the sheath from the femoral and delivered the catheter to the desired position.Then attempted to begin pumping, but the balloon did not inflate.Therefore, the catheter was promptly removed and replaced in the same site with a new one, with which the iabp worked normally.There was no reported injury.
Additional Manufacturer Narrative
Qn# (b)(4).No serial number was reported.The serial number on the returned sample is ck20428.The lot number (18f22c0019) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed ziploc bag.Returned with the sample was supplied data-scope inflation driveline tubing; no damage or abnormalities were noted.Dried blood was noted on the exterior surfaces of the returned data-scope inflation driveline tubing.Upon return, the teflon sheath was noted on some portion of the iabc bladder; the distal end of the teflon sheath was at approximately 18.7cm from the iabc distal tip and liquid blood was noted within the sheath sidearm.Buckling to the teflon sheath extrusion was noted at approximately 13.4cm to 15.2cm from the distal tip of the teflon sheath.The one-way valve was tethered to the short driveline tubing.The exposed portion of the bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned iabc.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.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 risk is acceptable.The returned device passed visual and functional testing.The reported complaint that the "balloon did not inflate" is not confirmed.The returned intra-aortic balloon catheter (iabc) bladder was fully intact with no abnormalities noted.During functional testing, the iabc bladder inflated and deflated completely with no alarms noted.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 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15920670
• Report Number: 3010532612-2022-00524
• Device Sequence Number: 6562672
• Product Code: DSP
• UDI-Device Identifier: 00801902136701
• UDI-Public: 00801902136701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 02/28/2024
• Device Model Number: IPN038074
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22C0019
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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
• Patient Sex: Unknown