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

Catalog Number IAB-05830-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Left Ventricular Dysfunction (1947)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported by the registered nurse (rn) in the cardiovascular intensive care unit (cvicu) that a patient had an intra- aortic balloon (iab) inserted via a sheath a week ago.The iabp alarmed helium loss last night and there was blood observed in the gas tubing.There were no complications to the patient.They were able to successfully remove the balloon with no issues last night.The patient is stable now without the pump.They did not replace the balloon.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.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.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.No product was returned for evaluation.If the product is returned at a later date, a full investigation will take place.The root cause of the complaint is undetermined.

Event Description

It has been reported by the registered nurse (rn) in the cardiovascular intensive care unit (cvicu) that a patient had an intra- aortic balloon (iab) inserted via a sheath a week ago.The iabp alarmed helium loss last night and there was blood observed in the gas tubing.There were no complications to the patient.They were able to successfully remove the balloon with no issues last night.The patient is stable now without the pump.They did not replace the balloon.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5670449
• MDR Text Key: 45648444
• Report Number: 1219856-2016-00119
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F15M0004
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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