MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 8FR 50C; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038265
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "balloon would not fully inflate".As a result, the catheter was removed and a 2nd iab was inserted.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the "balloon would not fully inflate".As a result, the catheter was removed and a 2nd iab was inserted.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00319.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of iab "50cc balloon not inflating" was not able to be confirmed as the product was not returned for investigation.A device history record (dhr) review was conducted based on the shipping history no relevant findings were identified.All devices passed manufacturing specifications prior to release.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.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: section d.1.-brand name corrected to ultraflex iab: 8fr 50c section d.4.-catalog# corrected to iab-06850-u.
Event or Problem Description
It was reported that the "balloon would not fully inflate".As a result, the catheter was removed and a 2nd iab was inserted.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3010532612-2023-00319.

• Brand Name: ULTRAFLEX IAB: 8FR 50C
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17099225
• Report Number: 3010532612-2023-00320
• Device Sequence Number: 7812789
• Product Code: DSP
• UDI-Device Identifier: 10801902144208
• UDI-Public: 10801902144208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2023

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 Model Number: IPN038265
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 07/11/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/13/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown