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

Model Number IPN000260

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was blood found in the helium chamber of the intra-aortic balloon (iab) after working for 10 minutes.As a result, the intra-aortic balloon pump (iabp) was shut down immediately and the iab was removed.The user used a new iab to complete the treatment.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 of iab blood in helium pathway is confirmed.During the investigation, dried blood was confirmed within the iabc helium pathway.During the investigation, the leak testing of the iabc was unable to be performed successfully.The iabc outer lumen was noted blocked by dried blood and was not able to be cleared.The bladder/helium pathway could not be inflated, and any potential leak site(s) could not be determined.The root cause how the blood entered in the helium pathway is undetermined.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 there was blood found in the helium chamber of the intra-aortic balloon (iab) after working for 10 minutes.As a result, the intra-aortic balloon pump (iabp) was shut down immediately and the iab was removed.The user used a new iab to complete the treatment.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11656409
• MDR Text Key: 245127516
• Report Number: 3010532612-2021-00116
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F20G0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 55