MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Cardiogenic Shock (2262); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the chief of perfusion that a patient with an intra-aortic balloon (iab) ruptured.The rupture occurred approximately an hour ago in the cardiovascular intensive care unit (cvicu).Blood was noted in the tubing just prior to an unspecified alarm on the intra-aortic balloon pump (iabp).The iab was removed without incident or noted complication.The md chose not to reinsert at this time.The iab was inserted pre-op in the cath lab and later the patient was also placed on extracorporeal membrane oxygenation (ecmo) life support.The patient is currently critical and supported on ecmo.The chief of perfusion reports worsening pulses to the foot over the last 24hours but is not convinced this was isolated to the iab/iabp, patient has no previous peripheral vascular disease (pvd) history.He is wondering how much the ecmo aortic cannula could have affected or caused the iab rupture.There is no patient death reported, however, patient current condition is critical.Iab was removed and therapy terminated.Per additional note: chief of perfusion, stated that the iab event did not cause any known complications or contribution to patient's current critical status.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.The iab central lumen was found broken near the iab bifurcate which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause could not be determined but a potential root cause of the broken central lumen is a result of patient movement.A device history record (dhr) review was conducted for the lot 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.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the chief of perfusion that a patient with an intra-aortic balloon (iab) ruptured.The rupture occurred approximately an hour ago in the cardiovascular intensive care unit (cvicu).Blood was noted in the tubing just prior to an unspecified alarm on the intra-aortic balloon pump (iabp).The iab was removed without incident or noted complication.The md chose not to reinsert at this time.The iab was inserted pre-op in the cath lab and later the patient was also placed on extracorporeal membrane oxygenation (ecmo) life support.The patient is currently critical and supported on ecmo.The chief of perfusion reports worsening pulses to the foot over the last 24hours but is not convinced this was isolated to the iab/iabp, patient has no previous peripheral vascular disease (pvd) history.He is wondering how much the ecmo aortic cannula could have affected or caused the iab rupture.There is no patient death reported, however, patient current condition is critical.Iab was removed and therapy terminated.Per additional note: chief of perfusion, stated that the iab event did not cause any known complications or contribution to patient's current critical status.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7346318
• MDR Text Key: 102723333
• Report Number: 3010532612-2018-00045
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17K0038
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1