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 02/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and the staff noted blood thru the helium line to the intra-aortic balloon pump (iabp).The staff turned off the iabp and did not call cath lab until the next day to exchange.The iab was removed and replaced with a 50cc iab the next day and inserted using the same insertion site.There was no report of patient complications serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint 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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and the staff noted blood thru the helium line to the intra-aortic balloon pump (iabp).The staff turned off the iabp and did not call cath lab until the next day to exchange.The iab was removed and replaced with a 50cc iab the next day and inserted using the same insertion site.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: 11453003
• MDR Text Key: 238857844
• Report Number: 3010532612-2021-00044
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F20K0023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 98