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

Model Number IPN000257

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the during the intraoperative examination, it was noted that the balloon was damaged.As a result, a new intra-aortic balloon (iab) was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint iab catheter damaged is confirmed.During the investigation, the iabc central lumen was noted damaged/broken in the flex tip assembly area, which can cause blood to enter the helium pathway.The iabc bladder membrane was fully intact, with no leaks noted.The root cause of the complaint is undetermined.A potential cause is customer handling.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

It was reported that the during the intraoperative examination, it was noted that the balloon was damaged.As a result, a new intra-aortic balloon (iab) was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12331350
• MDR Text Key: 266882900
• Report Number: 3010532612-2021-00244
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F20H0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1