MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

This complaint is being generated for a finding found during the investigation.While the device was being investigated it was found that the device had blood in the helium pathway and the balloon was ruptured.As a result, the complaint has been generated to capture the finding.Additional information received.During surgery the balloon ruptured and the surgeon had to cut the balloon to remove clot and remove the iab from the patient.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed based on visual inspection of the device.Damage to the iab bladder and a broken central lumen was noted during the complaint investigation, which can cause blood to enter the helium pathway.However, the cause of the complaint was unable to be determined due to the returned state of the device.The root cause of how the blood entered the helium pathway is undetermined, the sample was returned too damaged to fully analyze.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 risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

This complaint is being generated for a finding found during the investigation.While the device was being investigated it was found that the device had blood in the helium pathway and the balloon was ruptured.As a result, the complaint has been generated to capture the finding.Additional information received.During surgery the balloon ruptured and the surgeon had to cut the balloon to remove clot and remove the iab from the patient.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8275362
• MDR Text Key: 134016900
• Report Number: 3010532612-2019-00004
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18B0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1