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 Rupture (1546)

Patient Problems Air Embolism (1697); Paresis (1998); Weakness (2145)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the registered nurse that blood was noted in the gas line tubing.The rn stated that there was no issue with placement of the intra-aortic balloon (iab) catheter, but once the patient was transferred, the patient experienced "left sided weakness" and blood was noted in the tubing.The intra-aortic balloon pump (iabp) had a helium loss alarm.The left sided weakness was resolved after removal of the iab.As a result, the catheter was removed without incident, and no other catheter was reinserted.There was a potential helium embolism questioned by the md.There was a report of delay in therapy and patient complication.There was no report of patient death.The patient was being monitored and stable.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in the helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the broken fiber is undetermined.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 registered nurse that blood was noted in the gas line tubing.The rn stated that there was no issue with placement of the intra-aortic balloon (iab) catheter, but once the patient was transferred, the patient experienced "left sided weakness" and blood was noted in the tubing.The intra-aortic balloon pump (iabp) had a helium loss alarm.The left sided weakness was resolved after removal of the iab.As a result, the catheter was removed without incident, and no other catheter was reinserted.There was a potential helium embolism questioned by the md.There was a report of delay in therapy and patient complication.There was no report of patient death.The patient was being monitored and stable.

• 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: 8052753
• MDR Text Key: 126589489
• Report Number: 3010532612-2018-00333
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18B0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IV VASOPRESSORS; IV VASOPRESSORS; IV VASOPRESSORS