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

Model Number	IPN039788
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloon could not move forward normally after insertion, after checking it, it was found that the catheter was severely kinked and could not be used normally, so a new catheter was replaced for smooth insert." additional information states that the secondary catheter was inserted at the same insertion site.No report of patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f22c0022) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a clear plastic bag.Upon return, the peel away sheath was noted on the returned iabc.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.A kink to the iabc central lumen was noted at approximately 22.4cm 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 damage or abnormalities were noted to the returned sample.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 syringe.No abnormalities or debris were noted.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.A guidewire was back loaded through the iabc distal tip.The guidewire could not advance at approximately 22.4cm from the iabc distal tip, which is the location of the previously noted kink.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 59.6cm from the iabc luer, which is the location of the previously noted kink.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 compliant of iab kinked is confirmed.A kink to the central lumen was noted during the visual inspection of the returned iab catheter, and a guidewire could not pass successfully through the iabc central lumen during functional testing.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 kinked central lumen.The root cause of the kink is undetermined.The most probable potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported that "the balloon could not move forward normally after insertion, after checking it, it was found that the catheter was severely kinked and could not be used normally, so a new catheter was replaced for smooth insert." additional information states that the secondary catheter was inserted at the same insertion site.No report of patient harm or injury.

• 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: 15615945
• Report Number: 3010532612-2022-00409
• Device Sequence Number: 20851351
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 02/28/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22C0022
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 69 YR
• Patient Sex: Male