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

Catalog Number IAB-05830-LWS

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on a patient, blood was noticed in the helium drive line.As a result, therapy was stopped and the iab was removed.There was no reported patient death or patient complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in the helium pathway is confirmed.The bladder had a full thickness abrasion which allowed blood to enter the iab.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.A device history record (dhr) review was conducted for the lot number/serial 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.No further action required.Other remarks: additional information received: the catheter became stuck during removal and required the cut down to extract the catheter.A clamp was applied and the patient had good hemostasis with no hematoma/bruit.The clamp was removed after 75 minutes and the patient had stable vitals.(b)(4).

Event Description

It was reported that during use on a patient, blood was noticed in the helium drive line.As a result, therapy was stopped and the iab was removed.There was no reported patient death or patient complications.

• 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: 7119455
• MDR Text Key: 95003631
• Report Number: 1219856-2017-00333
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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-05830-LWS
• Device Lot Number: 18S16K0017
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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