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

Model Number	IPN915322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that after the catheter was inserted, the balloon was found to be ruptured.A second catheter was inserted at the same insertion site.No medical intervention necessary.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 (18f22f0051) recorded on the complaint report matches the lot number on the returned original packaging box and for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with an original packaging box that matches the serial number on the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging box.Returned with the sample was supplied data-scope inflation driveline tubing.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc outer lumen was noted damaged with flattened surface at approximately 29.2cm to 31cm 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.No other visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0057in-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.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood exited.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood noted on the guidewire.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood 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 risk is acceptable.The returned device passed visual and functional testing.The reported complaint of iab leak suspected is not confirmed.During the visual inspection of the returned sample, no blood was noted within the helium pathway.The returned intra-aortic balloon catheter (iabc) was functionally tested with no leaks or 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that after the catheter was inserted, the balloon was found to be ruptured.A second catheter was inserted at the same insertion site.No medical intervention necessary.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: 16122267
• Report Number: 3010532612-2023-00016
• Device Sequence Number: 18249501
• 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,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: 18F22F0051
• 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: 02/23/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown