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

Catalog Number IAB-05830-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the rn called and stated that they had a female patient (pt) with a 30cc fiberoptix intra-aortic balloon (iab) that was inserted around midnight on (b)(6) 2015.Indication for use: three vessel disease.The iab was removed because they had two "high pressure" alarms and could not figure out what the problem was.They also noted that there was blood backing up in the transducer tubing of the central lumen.The rn stated that the pt was not moving or coughing, was in a sinus rhythm and did not have any pressors infusing.They had straightened the tubing and tried to flush the central lumen.The clinical support specialist (css) explained that the blood backing up in the transducer tubing was unrelated to the high pressure alarms, which was related to the gas going in and out of the balloon.The css explained that they might have tried to decrease the balloon volume for the high pressure alarm and checked the position of the balloon on x-ray.Since there was blood backing up in the central lumen, the css said she would have had them check the transducer set-up as there may have been a crack in the stopcock.The pt was stable without intra-aortic balloon pump (iabp) therapy and waiting to be evaluated for cabg (coronary artery bypass graft) surgery.

Manufacturer Narrative

(b)(4).Device evaluation: returned for evaluation was a 30cc 8.0fr iab fos.The central lumen was noted heavily kinked within the returned packaging.The bladder membrane was wrapped in bubble wrap and the entirety of the iab was held by a rubber band.After removing the rubber band it appeared the central lumen broke, as the iab unraveled out of the position it was returned in.It is possible the central lumen was already broken previously.The breaking point of the central lumen was located approximately 17.0cm from the luer end of the catheter.The fiber was also found broken in this location.The fiber was intact at the tip of the catheter.The one-way valve was not returned with the iab.Blood was noted within the bladder membrane.The fos connector and cal key were examined.The gray fos connecter was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no abnormalities were noted.The cal key was intact.See other remarks section for continuation.Other remarks: the cal key and fos were connected to the iabp.The cal key was recognized.The pump status was ll pl.The fiber was previously noted broken approximately 17.0cm from the luer end of the catheter.The fiber was intact at the tip of the catheter.The iab was submerged in water and leak tested.The catheter was found leaking through the distal tip of the catheter because of the broken central lumen; however, no holes or leaks were detected on the bladder membrane.The bladder membrane passed functional testing.The iab failed leak test.A device history record 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 high pressure alarms is not able to be confirmed.The iab could not be pump tested because of the condition it was returned in.Blood was found within the iab upon return; however, the event details did not make any note of this issue.The blood likely entered the iab as a result of the broken central lumen.The root cause of the broken central lumen is undetermined.

Event Description

It was reported that the rn called and stated that they had a female patient (pt) with a 30cc fiberoptix intra-aortic balloon (iab) that was inserted around midnight on (b)(6) 2015.Indication for use: three vessel disease.The iab was removed because they had two "high pressure" alarms and could not figure out what the problem was.They also noted that there was blood backing up in the transducer tubing of the central lumen.The rn stated that the pt was not moving or coughing, was in a sinus rhythm and did not have any pressors infusing.They had straightened the tubing and tried to flush the central lumen.The clinical support specialist (css) explained that the blood backing up in the transducer tubing was unrelated to the high pressure alarms, which was related to the gas going in and out of the balloon.The css explained that they might have tried to decrease the balloon volume for the high pressure alarm and checked the position of the balloon on x-ray.Since there was blood backing up in the central lumen, the css said she would have had them check the transducer set-up as there may have been a crack in the stopcock.The pt was stable without intra-aortic balloon pump (iabp) therapy and waiting to be evaluated for cabg (coronary artery bypass graft) surgery.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5360168
• MDR Text Key: 35681648
• Report Number: 1219856-2016-00006
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F15H0006
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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