MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the central lumen clotted during use on a patient.During therapy, blood was noted to be "creeping back" the central lumen tubing.There was an attempt to flush the central lumen, but could not.The intra-aortic balloon (iab) was not removed due to central lumen clotting off.The fiber optic sensor (fos) was working fine for signal and timing.As a result, the physician was notified and the central lumen was labeled to "not attempt to flush".There was no report of delay of interruption of therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "iab central lumen occluded" is not able to be confirmed.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.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.No further action required at this time.

Event Description

It was reported that the central lumen clotted during use on a patient.During therapy, blood was noted to be "creeping back" the central lumen tubing.There was an attempt to flush the central lumen, but could not.The intra-aortic balloon (iab) was not removed due to central lumen clotting off.The fiber optic sensor (fos) was working fine for signal and timing.As a result, the physician was notified and the central lumen was labeled to "not attempt to flush".There was no report of delay of interruption of therapy.There was no report of patient complication or serious injury and death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• 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: 7388365
• MDR Text Key: 104135531
• Report Number: 3010532612-2018-00060
• 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: 03/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F17H0048
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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