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

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that they were unable to get an arterial pressure waveform and when the doctor attempted to flush the line it was leaking.Therefore, the md decided to remove the intra-aortic balloon catheter (iabc) and not replace it.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of central lumen occluded is confirmed.Upon aspiration and flushing, a large amount of blood exited the central lumen but the test was successfully completed.The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line.Numerous bends were also noted to the central lumen which can result in a dampened pressure reading.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 revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the rn that they were unable to get an arterial pressure waveform and when the doctor attempted to flush the line it was leaking.Therefore, the md decided to remove the intra-aortic balloon catheter (iabc) and not replace it.There was no report of patient complication or serious injury and death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7395446
• MDR Text Key: 104274266
• Report Number: 3010532612-2018-00067
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16K0006
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1