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

Catalog Number IAB-05830-LWS

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250)

Patient Problem Venipuncture (2129)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that the staff noticed blood in the intra-aortic balloon catheter (iabc) drive line when therapy was being delivered.Once the blood was noticed, pumping was stopped.As a result, the catheter was removed surgically.The pump alarmed kinked catheter.Patient outcome: reported as "fine".The intra-aortic balloon (iab) was not replaced with another iab.No reported patient death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.Two cuts consistent with contact from a sharp object were found on the bladder membrane which likely allowed blood to enter the helium pathway.The root cause of the bladder damage is undetermined.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.This issue will be monitored for any developing trends.No further action required at this time.

Event Description

It has been reported that the staff noticed blood in the intra-aortic balloon catheter (iabc) drive line when therapy was being delivered.Once the blood was noticed, pumping was stopped.As a result, the catheter was removed surgically.The pump alarmed kinked catheter.Patient outcome: reported as "fine".The intra-aortic balloon (iab) was not replaced with another iab.No reported patient death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6930198
• MDR Text Key: 88956801
• Report Number: 1219856-2017-00222
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F17D0026
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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