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

Model Number	IPN039788
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that an "ultraflex 40cc balloon ruptured in the icu after two hours of working." a second iab was inserted at the same insertion site.No reported delay of treatment.No report of patient harm or injury.Patient status reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of iab leak suspected is confirmed based on the customer photo provided with the complaint report.The product was not returned for investigation.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 iabc leak.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that an "ultraflex 40cc balloon ruptured in the icu after two hours of working." a second iab was inserted at the same insertion site.No reported delay of treatment.No report of patient harm or injury.Patient status 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: 15715589
• Report Number: 3010532612-2022-00488
• Device Sequence Number: 4873440
• Product Code: DSP
• UDI-Device Identifier: 10801902145731
• UDI-Public: 10801902145731
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 05/31/2024
• Device Model Number: IPN039788
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22F0010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown