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

Catalog Number IAB-06840-U

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a corrected data: n/a.

Event Description

It was reported via medwatch that "when patient returned from cath lab, iab appeared to be ruptured.Iab was then removed at bedside by md.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.

Manufacturer Narrative

Qn#(b)(4).The reported complaint for iab "appeared to be ruptured" is not able to be confirmed.The product was not returned for investigation.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.The reported complaint will be monitored for any developing trends.

Event Description

It was reported via medwatch that "when patient returned from cath lab, iab appeared to be ruptured.Iab was then removed at bedside by md".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.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18467623
• MDR Text Key: 332975322
• Report Number: 3010532612-2024-00028
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23G0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1