MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S730C

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 08/17/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms.The perfusionist was called to troubleshoot.There were no signs of blood in the tubing, or a kink and all the connections were tight.The alarm stopped.During the morning, the staff again experience "possible helium loss" alarm.At this time it was noticed there was a slight amount of blood in the gas drive tubing.As a result, the cardiologist was notified and the iab was removed with difficulty.The patient was sent to the operating room (or) for removal.A second iab was inserted on the right femoral artery.The vascular surgeon had to cut the iab to get the iab out.A clot was noted in the balloon.There was a report of patient's death after returning to the intensive care unit.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "blood in helium pathway" is not able to be confirmed.The product was not returned for investigation.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms.The perfusionist was called to troubleshoot.There were no signs of blood in the tubing, or a kink and all the connections were tight.The alarm stopped.During the morning, the staff again experience "possible helium loss" alarm.At this time it was noticed there was a slight amount of blood in the gas drive tubing.As a result, the cardiologist was notified and the iab was removed with difficulty.The patient was sent to the operating room (or) for removal.A second iab was inserted on the right femoral artery.The vascular surgeon had to cut the iab to get the iab out.A clot was noted in the balloon.There was a report of patient's death after returning to the intensive care unit.

• Brand Name: REDIGUARD IAB: 7FR 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: 7873585
• MDR Text Key: 120158662
• Report Number: 3010532612-2018-00285
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981660
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S730C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Death