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

Catalog Number IAB-05840-LWS

Device Problems Partial Blockage (1065); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that the balloon pressure waveform (bpw) looks narrow, the ecg trigger is good, but the central lumen is dampened.There is some variation with the timing due to the dampened waveform.Staff aspirated and flushed the central lumen and reposition the patient but the waveform did not improve much.The bpw showed some kinking to the catheter and the bpw improved some with the repositioning.The patient had a radial line therefore the clinical support specialist (css) had them connect the radial line to the pump and the central lumen to the monitor.Now that the radial line is on the pump, the timing has improved and the bpw appears more normal.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of the iab central lumen being occluded is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the rn that the balloon pressure waveform (bpw) looks narrow, the ecg trigger is good, but the central lumen is dampened.There is some variation with the timing due to the dampened waveform.Staff aspirated and flushed the central lumen and reposition the patient but the waveform did not improve much.The bpw showed some kinking to the catheter and the bpw improved some with the repositioning.The patient had a radial line therefore the clinical support specialist (css) had them connect the radial line to the pump and the central lumen to the monitor.Now that the radial line is on the pump, the timing has improved and the bpw appears more normal.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• 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: 8885840
• MDR Text Key: 154121443
• Report Number: 3010532612-2019-00262
• Device Sequence Number: 1
• Product Code: DSP
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19D0052
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATED; VENTILATED