MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000257

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "on (b)(6) 2022, a doctor in (b)(6) hospital, found that there was no display of the balloon connection interface after balloon implantation.After the balloon was withdrawn from the body, it was found that the anterior segment of the balloon was broken, and a new set of catheter was replaced".Additional information received stated that the "balloon was found to be ruptured".No patient injury, harm, or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of iab leak suspected 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 that "on (b)(6) 2022, a doctor in (b)(6) hospital, found that there was no display of the balloon connection interface after balloon implantation.After the balloon was withdrawn from the body, it was found that the anterior segment of the balloon was broken, and a new set of catheter was replaced".Additional information received stated that the "balloon was found to be ruptured".No patient injury, harm, or consequence reported.Patient condition reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15224375
• MDR Text Key: 305355942
• Report Number: 3010532612-2022-00314
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22D0023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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
• Treatment: NONE REPORTED; NONE REPORTED