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

Model Number	IPN039788
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The report states "on (b)(6) 2022, (b)(6) opened the catheter package and implanted it normally.During the operation, it was found that the connection between the catheter head and the balloon tube was broken and could not be used normally".A new catheter was inserted at the same insertion site.No report of patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states "on (b)(6), 2022, (b)(6) opened the catheter package and implanted it normally.During the operation, it was found that the connection between the catheter head and the balloon tube was broken and could not be used normally".A new 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 reported lot number (18f21e0021) 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 on the iabc; the peel-away sheath was noted partially "peeled" or partially removed.The one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped; additionally, the catheter bladder was noted damaged by the central lumen and the distal tip was separated and no longer attached to the central lumen.A kink was noted to the iabc approximately 72.6cm from the central lumen distal tip.A bend was noted to the central lumen approximately 5.2cm from the central lumen distal tip.No obvious blood was noted.A small amount of dried blood was noted within the helium pathway/short driveline tubing.The customer photo submitted was reviewed; the photo shows the iab catheter bladder damaged by the central lumen and the distal tip was separated and no longer attached to the central lumen, which is consistent with the reported complaint.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 for iab "connection between the catheter head and the balloon tube was broken" is confirmed.During the investigation, the iab catheter distal tip was separated and no longer attached to the central lumen.Damage was also noted to the bladder because of the central lumen and distal tip separation.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 to the distal tip separation.The root cause is manufacturing related.A non-conformance has been initiated to further investigate the issue.

• 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: 15615925
• Report Number: 3010532612-2022-00412
• Device Sequence Number: 17663078
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F21E0021
• 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: 11/11/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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 Sex: Male