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

Model Number	IPN915322
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "in the endocardial catheterization laboratory of (b)(6) hospital, iabp was inserted to assist cardiac function after cag+ptca.The operator inserted the balloon along the sheath, but it could not be fully inserted.The operator moved the balloon position slightly, but it still could not be inserted.The operator withdrew the balloon, a one-way valve was connected, but it still could not be inserted completely.After withdrawing the balloon, it was replaced with a new catheter; it is normal".The 2nd iab was inserted at the same insertion site.The patient condition 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 reported lot number (18f22h0038) matches the lot number for the returned packaging and for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging that matches the serial number on the returned sample.Upon return, the peel away sheath was noted on the returned iabc.Additionally, the iabc was noted with a teflon sheath on the iabc; the distal end of the teflon sheath was noted at approximately 11.2cm from the iabc distal tip and was covering a portion of the bladder.The exposed section of the bladder was noted loosely wrapped.The one-way valve was tethered to the short driveline tubing and a supplied 60cc syringe was noted inserted/connected to the one-way valve; no damage or abnormalities were noted to the syringe.Bends to the iabc were noted at approximately 5.3cm and 9.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.Returned with the sample was an assembled 8fr teflon sheath and dilator.The sheath and dilator appeared typical with no damage or abnormalities.The bladder thickness was measured at six points with measurements ranging from 0.0065in-0.0068in.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.The catheter's central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some dried blood was noted.Upon receipt, the sheath was noted on a section of the bladder membrane, however there is no evidence that the user attempted to remove the iabc and bladder through the sheath.The issue reported was for insertion difficulty.The sheath on the iabc was inspected and noted as typical/undamaged.The one-way valve was connected to the short driveline tubing and a vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was moved from the bladder and towards the bifurcate without difficulty.The bladder appeared typical; no damage or abnormalities were noted to the bladder.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.4cm and 9.7cm from the iabc distal tip, which are the locations of the previously noted bends.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 73cm from the iabc luer, which is the location of a previously noted bend.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 of iab insertion difficulty is confirmed.The intra-aortic balloon catheter (iabc) was returned with bends to the central lumen.The damaged iabc can result in difficulty inserting the iabc into the patient.The returned iabc bladder membrane and sheath passed inspection.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 bent central lumen.The root cause of the bends 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 that "in the endocardial catheterization laboratory of (b)(6) hospital, iabp was inserted to assist cardiac function after cag+ptca.The operator inserted the balloon along the sheath, but it could not be fully inserted.The operator moved the balloon position slightly, but it still could not be inserted.The operator withdrew the balloon, a one-way valve was connected, but it still could not be inserted completely.After withdrawing the balloon, it was replaced with a new catheter; it is normal".The 2nd iab was inserted at the same insertion site.The patient condition 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: 16418720
• Report Number: 3010532612-2023-00129
• Device Sequence Number: 5631910
• 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): 02/21/2023

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: 07/31/2024
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22H0038
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 60 KG